Product Recall What Ti Synex II Vertebral Body

Product Recall What: Ti Synex II Vertebral Body Replacement Recall Date: November 9, 2009 [1] Why: The device is used to replace damaged vertebrae in the T 1 -L 5 portion of the spine. Reports of moderate to severe loss of vertebral body replacement height at 6 to 15 months post implantation were received. Side effects include neural injury, increased pain, spinal kyphosis, failure of supplementary fixations, and need for reoperation. [2] Incidents: The FDA made the decision to recall after 6 patients had the replacement collapse inside their spines. [3] Several other patients reported systems of decreased height (creating loss of spinal integrity), and increased back pain, along with the side effects listed above. [2] Number of Units Sold: 71 units in commerce. [1] When Sold: Distributed from July 2, 2007 to September 8, 2009. Manufactured from June 8, 2007 to September 9, 2009. [4] ETM 627 Monique Demers- Ti Synex II Vertebral Body Replacement 11/30/2014 1

Management Issues Recognition of Problem: The FDA issued a Class 1 recall, the most severe recall regarding products that will have severe adverse health effects or possible death [4]. The product was manufactured June 8, 2007 to September 9, 2009 [4] and 71 units were in commerce at the time of recall [1]. “Synthes USA issued an "Urgent: Medical Device Recall" letter to hospital accounts, Synthes personal and sales consultants dated September 23, 2009. Users were asked to take inventory, complete and return a Verification form and return all affected product to the firm. ” [1] Speed of Response: Synthes issued the “Urgent: Medical Device Recall” before the FDA issued the Class 1 recall. Due to the nature of the device, hospitals were notified to stop implementing it immediately and return the device to the company. Patients who experienced any of the symptoms were told to contact their surgeons immediately, while the company recommended monitoring of all other patients with the device. [1] Responsibility: Patients who received the device reported a positive experience initially. Once the company received reports of the collapsed devices, they issued a warning letter to hospitals and sales representative globally. The ETM 627 Monique Demers- Ti Synex II Vertebral Body Replacement company asked surgeons to stop using their device and due to the risk of 11/30/2014 complications. [3] 2

Impact of Recall Legal Consequences: Due to the nature of the device, it was possible to create a lawsuit showing that Synthes displayed neglect when testing. Several law firms created suits against Synthes recalled all devices that were not implanted, encouraged patients who currently had the device to talk to their doctors if they experienced any of the side effects, and if patients did not experience side effect, they were to be monitored to ensure the integrity of the device did not change. Reputation: Synthes is a world renowned medical device company. The recall does not appear to have had an affect on their reputation. The company acted quickly and encouraged patients to talk to their doctor and hospitals to immediately stop distributing the device and return all devices in inventory back to them. Sales: The rate of net profitability of Synthes remained on a steady rise until 2010, but their sales continued to increase from 2006 -2011. [5] . ETM 627 Monique Demers- Ti Synex II Vertebral Body Replacement 11/30/2014 3

Technical The human spine must be able to withstand 2 x the weight of the body. The integrity of the human spine effects the gait cycle. An improper gait cycle can lead to long term issues with the ankles, knees, hips, and back. The affected vertebrae was T 1 -L 5 ETM 627 Monique Demers- Ti Synex II Vertebral Body Replacement 11/30/2014 4

References [1] Class 1 Device Recall TI Synex (TM) II Central Body 84 mm 110 mm. (n. d. ). Retrieved November 26, 2014, from http: //www. accessdata. fda. gov/scripts/cdrh/cfdocs/cfres/res. cfm? id=85691 [2] FDA Classifies Synthes' Voluntary Medical Device Recall of Synex II Central Body Components as a Class I Recall. (n. d. ). Retrieved November 26, 2014, from http: //www. synthes. com/sites/NA/Pages/nov 4. aspx [3] Synex II Vertebral Body Replacement. (n. d. ). Retrieved November 26, 2014, from http: //www. mediafact. com/synthes-recall/synex. html [4] Synthes USA, Ti Synex II Vertebral Body Replacement (VBR). (n. d. ). Retrieved November 26, 2014, from http: //www. fda. gov/Medical. Devices/Safety/Listof. Recalls/ucm 190300. htm [5] SYST Stock Quote | Synthes Inc. Stock Price (SWX: SYST) | Swiss Exchange: SYST | 4 Traders. (n. d. ). Retrieved November 26, 2014, from http: //www. 4 -traders. com/SYNTHESINC-9365037/ ETM 627 Monique Demers- Ti Synex II Vertebral Body Replacement 11/30/2014 http: //cnx. org/resources/d 10 efffc 4747 ac 6 fb 6 cc 43 d 0 eab 897 b 4/Figure_38_01_07. jpg 5