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

Catalog Number 07.702.016S

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Type  Death  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Literature citation: janssen, i., et al.(2017).Risk of cement leakage and pulmonary embolism by bone cement-augmented pedicle screw fixation of the thoracolumbar spine.The spine journal, vol 17, pp 837-844.Additional device product code: lod.This report is for an vertecem v+, part 07.702.016s.Concomitant devices reported: depuy spine expedium, medtronic horizon longitude, synthes matrix spine.Pma/510k not available.The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following journal article: janssen, i., et al.(2017).Risk of cement leakage and pulmonary embolism by bone cement-augmented pedicle screw fixation of the thoracolumbar spine.The spine journal, vol 17, pp 837-844.This was retrospective review of patients who had cement-augmented pedicle screw instrumentation (capsi) of the thoracolumbar spine between january 2012 and june 2015.A total of 165 patients were included in the study with an average age of 71 (ranging from 46-93 years old) and also included 62 males and 103 females.The purpose of the study was to assess the rate of capsi-associated complications.Patients were treated for osteoporotic fractures, spinal metastasis, degenerative or infectious spine diseases, and traumatic vertebral fractures with associated osteoporosis.Fifty-two of the patients had a neurological deficit; all had pain.Each patient was implanted with 2-21 cement-augmented pedicle screws.Intra-operative three-dimensional fluoroscopy-based navigation was used in most cases, while others were placed freehand.Some patients had a planned two-staged surgery with a second operation 3-4 weeks postop for vertebral body replacement, interbody fusion and/or extreme lateral interbody fusion.Patients with pce were treated with iv heparin followed by oral anticoagulants for approximately 6 months post op.Author confirmed complained device is vertecem v+.The following complications were reported with vertecem v+ bone cement: 2 = intraoperative hemo-dynamic reaction after starting cement application requiring cpr, severe pce verified on chest ct in central pulmonary artery and one case was also in the right atrium with subsequent cardiac failure; one of these cases there was suspicion of extravasation on intraoperative fluoroscopy; both patients died within 48 hours after surgery due to cardiogenic shock.This is report #1 of #5 for (b)(4).This report is for vertecem v+, part 07.702.016s, lot number and quantity unknown.

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6826607
• MDR Text Key: 83858362
• Report Number: 2520274-2017-12003
• 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
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.016S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention