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 Type  malfunction  

Event Description

This report is being filed after subsequent review of the following article: pavlov et al (2004) good outcome and restoration of lordosis after anterior lumbar interbody fusion with additional posterior fixation.Spine volume 29, number 17, pp 1893¿1900.(the netherlands) the aim of this study was to test the clinical performance of anterior lumbar interbody fusion (alif) with syncage, with emphasis on the safety and efficacy of the surgical procedure and the ability to restore anatomy and fuse the motion segment.Thirty-three patients underwent single-level and 19 patients double-level anterior lumbar interbody fusion with syncage and additional posterior fixation (translaminar screws, n=32 or pedicle screws, n=10).Radiologic and functional results (vas and oswestry score) were evaluated.This report refers to complications: subsidence of the cage was seen in two patients at l4¿l5 and in one patient at l5¿s1 three months after surgery.In another patient, there was subsidence of both cages (l4¿l5¿s1), with no further consequences.This is report 5 of 6 for com-(b)(4).This report is for an unknown syncage, unknown part#/lot# and unknown quantity.A copy of the literature abstract is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional manufacturer narrative: pavlov et al (2004) good outcome and restoration of lordosis after anterior lumbar interbody fusion with additional posterior fixation.Spine volume 29, number 17, pp 1893¿1900.This report is for unknown syncage/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: 4785012
• MDR Text Key: 5860089
• Report Number: 2520274-2015-13924
• 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: 05/05/2015

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: 05/05/2015
• Initial Date FDA Received: 05/20/2015
• 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