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

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Choi, j; et al (2017) single-stage transpedicular vertebrectomy and expandable cage placement for treatment of unstable mid and lower lumbar burst fractures.This report is for an unknown synex cage (unknown quantity/unknown lot).The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.(b)(4).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 subsequent review of the following literature article: choi, j; et al (2017) single-stage transpedicular vertebrectomy and expandable cage placement for treatment of unstable mid and lower lumbar burst fractures.Clin spine surg; 30:2, e257-e263.This is a retrospective study to examine the single-stage transpedicular vertebrectomy and expandable cage placement for treatment of unstable mid and lower lumbar burst fractures (below the l3).From 2009 and august 2011, eleven patients (5 women, 6 men) underwent surgical intervention using an expandable titanium cage (synex; synthes, (b)(4)) under circumstances that indicated mechanical instability, progressively worsening neurological status, and/or back pain unresponsive to nonsurgical treatment.There was 1 intraoperative complication; patient 11 experienced inadvertent dural tear while expanding the cage, which was managed with simple repairing.There was 1 late postoperative complication; patient 9 developed cage subsidence at the upper end 2 months postoperatively.A copy of the article will be submitted with the medwatch.This report is 1 of 2 for (b)(4).This report is for an unknown synex cage and refers to the serious injury of patient 9, (b)(6) male who experienced subsidence.

Manufacturer Narrative

Corrected data: original report stated, patient 9, (b)(6) male who experienced subsidence as a serious injury; revising report is captured as a serious injury/ reportable malfunction.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 for an unknown synex cage and refers to the serious injury/reportable malfunction of patient 9, (b)(6) male who experienced subsidence.

Manufacturer Narrative

Device used for treatment, not for diagnosis.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 6878833
• MDR Text Key: 86748795
• Report Number: 2520274-2017-12297
• 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,Followup,Followup
• Report Date: 09/06/2017

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: 09/06/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 09/20/2017; 09/25/2017
• Supplement Dates FDA Received: 09/21/2017; 09/25/2017
• 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: 73 YR