MAUDE Adverse Event Report: SYNTHES SELZACH VERTEBRAL BODY STENT Ø17 X 15MM; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 09.804.401S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event date: (b)(6) 2010 is the date of original surgery, not when malfunction occurred.(b)(4) for recovered with permanent damage.This report is for one unknown vbs/unknown lot number.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes (b)(4) reports an event in (b)(6): it was reported that adjacent fracture required x-rays mri and was treated with pharmacological treatment and physiotherapy (resulted in re-hospitalization or prolongation of existing hospitalization).No material will be returned.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).Device has not been reported as explanted device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).Manufacturing date: 18august2009.Expiry date: 01july2012.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VERTEBRAL BODY STENT Ø17 X 15MM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5033704
• MDR Text Key: 24190872
• Report Number: 2520274-2015-15510
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2012
• Device Catalogue Number: 09.804.401S
• Device Lot Number: 0609025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention