MAUDE Adverse Event Report: SYNTHES SELZACH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Failure to Align (2522)

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

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Udi # (b)(4).Implant and explant dates: device malfunction occurred during the procedure.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation as the material was reportedly discarded.Initial reporter contact number: (b)(4).Pma 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.Device history records review was completed for part # 07.702.016s, lot # 5e53130.Manufacturing location: (b)(4).Manufacturing date: sep 09, 2015 expiry date: may 31, 2018.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device 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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, patient underwent initial surgery for percutaneous with vertebral augmentation.During the surgery, the handle of the mixer became stuck and made it impossible to use the cement.Another cement was used.The cement was injected into the vertebra l1 in which two stents were deployed.The surgery was prolonged about five (5) minutes.No impact to patient reported.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for (b)(4).

• Brand Name: VERTECEM V+ CEMENT KIT
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6105889
• MDR Text Key: 60032381
• Report Number: 3000270450-2016-10275
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 5E53130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1