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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Karches c., friedl w.(2002) secondary dislocation after synex cage implantation.Unfallchirurg· 105:744-747.This report is for unknown synex cage/unknown quantity/unknown lot.(b)(4).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 literature article; karches c., friedl w.(2002) secondary dislocation after synex cage implantation.Unfallchirurg 105:744-747.(germany).The authors describe four cases of dislocation of the synex-cage.For the ventral instrumentation of spine fractures these patients were treated with titanium-cages (synex, synthes), bone cement and cortico-spongious pelvis bone.Case 4: (b)(6) female patient presented with the indication for surgery with therapy-resistant pain and reduction of height of l1 vertebrae (presented with l1 fracture).L1 was resected via a left retroperitoneal approach, and treated with synex cage, competitor's plate and spongiosa.Postoperative radiographs showed sinking in and minor dislocation of the cage.Mobilization was reduced and treatment was carried on conservatively.This report refers to case 4: sinking and minor dislocation of the cage post-operatively this is report 4 of 4 for (b)(4).This report is for an unknown synex cage.

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5159498
• MDR Text Key: 28608765
• Report Number: 2520274-2015-16457
• 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
• Report Date: 10/01/2015

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: Not provided
• Initial Date FDA Received: 10/19/2015
• 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: 76 YR