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

Catalog Number 07.702.016S

Device Problem Leak/Splash (1354)

Patient Problems Anaphylactic Shock (1703); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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, lot number and quantity unknown.Concomitant devices reported: depuy spine expedium (unknown part number, lot number quantity), medtronic horizon longitude (unknown part number, lot number quantity), synthes matrix spine (unknown part number, lot number quantity).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.(b)(6).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.The following complications were reported with vertecem v+ bone cement: 31 cases = intraoperative suspicion of cement leakage detected on fluoroscopy without any hemodynamic relevance; 29 of those had post-op x-ray or ct scan for hardware control-confirmed cement leakage in prevertebral veins or inferior vena cava; then 8 had thoracic cts to exclude asymptomatic pulmonary cement emboli (pce), one became symptomatic; 3 cases had a confirmed pce but asymptomatic.1 = intraoperative hemo-dynamic reactions after starting cement application and required cpr 3 = symptomatic 1 day post-op with pce confirmed via chest ct.5 = asymptomatic pce found on postop imaging (chest x-ray or spine ct) within 4 days of surgery; and one was found on abdominal ct due to abdominal pain; pce localized in central pulmonary arteries and some were also in right atrium while other pces were found in subsegment and peripheral pulmonary arteries.68 = no intra-operative suspicion of cement leakage but had cement extrusion in prevertebral veins but no pce found on postop imaging and not further work up done because clinically asymptomatic 10 = epidural cement leakage: one level laminectomy for cement removal, second surgery due to aggravated radicular pain one day post op, and others were detected on post op imaging without further consequences revision surgery: to remove intraspinal cement extravasation and post op hematoma due to increase radicular pain post op, post op csf leak, and a wound infection.This is report #4 of #5 for (b)(4).This report is for vertecem v+, part 07.702.016s, lot number and quantity unknown.A copy of the literature article is being submitted with this medwatch.

• Brand Name: VERTECEM V+ CEMENT KIT
• Type of Device: NDN 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: 6756123
• MDR Text Key: 81469124
• Report Number: 2520274-2017-12016
• 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: 07/31/2017
• 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): Required Intervention