MAUDE Adverse Event Report: SYNTHES SELZACH VBS W/BALLOON MED; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 09.804.601S

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa.Implant date: implanted during the week 51 - 2015.Explant date: not explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4) supplier: (b)(4), manufacturing date: 22.Feb.2012, expiry date: 01.Jan.2015, no anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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) as follows: it was reported that an expired stent vbs was implanted at the hospital of rennes at neurosurgery service during the week 51 - 2015.Expiration date 01/2015.No prolongation in surgery.No patient impact.Patient is quite well.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).(b)(6).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: VBS W/BALLOON MED
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach 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: 5360030
• MDR Text Key: 35680513
• Report Number: 3000270450-2016-10009
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Catalogue Number: 09.804.601S
• Device Lot Number: 1211021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1