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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2003

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following literature article: gercek.E., arlet v., delisle j., marchesi d.(2003) subsidence of stand-alone cervical cages in anterior interbody fusion: warning.Eur spine j 12: 513-516.(b)(4).The authors of this article retrospectively reviewed eight patients with cervical radiculopathy operated upon with anterior discectomy and fusion with a standalone titanium cervical cage (syncage-c, synthes usa).To assess possible subsidence or migration of the cage, three different radiographic measurements in the sagittal plane were taken for each case, postoperatively and at the latest follow-up.Radiologically, only three patients out of the eight studied (or four cages out of the nine inserted) did not show any change in the studied parameters.There was no case of anterior or posterior migration of the cage.Superior migration of the cage into the superior end plate was obvious on the lateral radiographs in two cases.Inferior cage migration into the inferior end plate was observed in two patients.Simultaneous superior and inferior end plate migration was observed in two cases.All the patients had functional radiographic evaluation, and no segmental motion or kyphosis was observed in any of these cases.This report refers to: patient# 3: cage migration in (b)(6) male, implant at level c6-c7.This is report 2 of 6 for (b)(4).This report is for an unknown syncage-c, unknown quantity/unknown lot.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional manufacturer narrative: this report is for unknown syncage c/unknown quantity/unknown lot.(b)(6).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.

• 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: 4781536
• MDR Text Key: 22151561
• Report Number: 2520274-2015-13859
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/19/2015
• 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 Age: 33 YR