MAUDE Adverse Event Report: SYNTHES USA; IMPLANT, FIXATION DEVICE, SPINAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Joint Disorder (2373)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature abstract: horsting, p., et al (2011).Peek-cages in lumbar fusion: mid-term clinical and radiological outcome.From december 2004 until august 2007, a total of 95 patients (21 double level, 74 single level) with degenerative disc disease from l3 to s1 were operated on.The primary outcome measure was re-operation.Secondary outcome measures were bony bridging within the cage based on ct-scan and clinical improvement measured by the oswestry score.The median duration of follow-up was 47.7 months (range 29.9 ¿ 61.6 months).In total 24 patients (25.3%) were re-operated after a mean of 21.9 months (range 6.7-46.9) of the initial surgery.Twenty-three patients (18 single-level, 5 double-level) were re-operated for symptomatic pseudarthrosis and one patient for a deep wound infection.In one double-level patient both levels were pseudarthrotic.A ct scan was performed in 89 patients (109 out of 116 levels; 94%); 43 levels (39.4%) in 41 patients were pseudarthrotic.The mean oswestry score improved from 28.1 to 16.0.No relation has been found between the oswestry score and radiological outcome in this population.In this review, a high number of reoperations after an anterior lumbar interbody fusion (alif) procedure with the synfix-lr cage was found, mainly due to pseudoarthrosis.In the opinion of the authors, the absence of posterior fixation may have lead to insufficient initial stability, creating suboptimal conditions for bony bridging, and thus solid fusion.This report is against an unknown number of synfix-lr cages regarding pseudarthrosis and a deep wound infection.

Manufacturer Narrative

The device was used for treatment, not diagnosis.Horsting, p., et al (2011).Peek-cages in lumbar fusion: mid-term clinical and radiological outcome.This report is for unknown synfix-lr cages/unknown quantity/unknown lot number.(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.(b)(4).

• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• 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: 4390277
• MDR Text Key: 5436301
• Report Number: 2520274-2015-10075
• Device Sequence Number: 1
• Product Code: JDN
• 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: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• 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