MAUDE Adverse Event Report: SYNTHES (USA); SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient¿s identification was not available for reporting.(b)(6).A.Rohlmann et al.(2008).Loads on a telemeterized vertebral body replacement measured in three patients within the first postoperative month, clinical biomechanics 23 (2008) 147¿158.This report is for one (1) unknown synex vertebral body replacement.Implant date reported as (b)(6) 2006.Device not reported as explanted.The investigation could not be completed; no conclusion could be drawn, as no product 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 literature article: a.Rohlmann et al.(2008).Loads on a telemeterized vertebral body replacement measured in three patients within the first postoperative month, clinical biomechanics 23 (2008) 147¿158.Germany.The study objective was to measure the loads acting on a telemeterized vertebral body replacement (vbr) in three patients within the first month postoperatively.The study was comprised of three patients (two males and one female) between the ages of 62-71.A telemeterized synex vertebral body replacement (vbr) was implanted in three patients.Implant dates range from 2006-2007.All patients ((b)(6)) had a compression fracture of their l1 vertebral body.Patient (b)(6) had an additional femoral hip fracture.Internal spinal fixation devices spanning two segments were in two patients and four segments in the third patient ((b)(6)) were implanted from the posterior to stabilize the spine.Manufacturer of the devices is unknown.In a second operation, a ventrolateral approach was used to remove parts of the fractured vertebral body and the adjacent discs, and to insert the telemeterized vbr in the niche created.An endplate with the appropriate spacer was mounted intraoperatively to the measuring implant so that the best implant height was achieved.Bone material from the iliac crest and the resected rib was used to cover the implant.The position of the vbr relative to the spine was derived from x-ray images.The internal spinal fixation device remained in the patient after insertion of the vbr.Six load components were measured for several exercises in upright and lying positions within the first postoperative month.The following complications were reported: one male patient, (b)(6), had implant subsidence and pain.The preload applied during implantation and the subsidence of the vbr within the first month were not measured.In addition, assistance by a physiotherapist during standing led in two of the three patients (specific patient was not noted in article).A few days after surgery the patients stood assisted by a physiotherapist.At that time they still suffered pain and were often not very confident.One day before leaving the hospital they were able to stand unsupported.The pain was much less and they were relaxed.This is report 1 of 3 for (b)(4).This report is for one (1) unknown synex vertebral body replacement, unknown part # / lot #.

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6986477
• MDR Text Key: 90522221
• Report Number: 2520274-2017-12546
• Device Sequence Number: 1
• Product Code: MQP
• 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
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/30/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 66