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

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

Patient Problems Tingling (2171); Alteration In Body Temperature (2682)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature abstract: strube, p., et al (2012).Stand-alone anterior versus anteroposterior lumbar interbody single-level fusion after a mean follow-up of 41 months.Journal of spinal disorders, 25, 362-369.A prospective cohort study comparing evaluations of single-level anterior lumbar interbody fusion (alif) versus anteroposterior lumbar fusion (aplf- other manufacturer device) was conducted to clinically and radiologically compare the outcome after angle-stable, locked, stand-alone alif with that obtained after aplf, in cases with degenerative disc disease (ddd) between march 2005 and april 2007.Eighty patients with chronic low-back pain due to a single-level ddd and facet joint arthritis were enrolled in this study.Forty patients ((19 male, 21 female) received an anteroposterior fusion (alif with transpedicular fixation: aplf group) and 40 patients ((20 male, 20 female) (alif group) were treated with a stand-alone alif using the synfix-lr device.At 7 days, 3, 6, 12, and 24 months, and at a mean follow-up of 41 months, patients were clinically (visual analog scale, oswestry low back pain disability index, satisfaction) and radiologically (x-ray, and at 12 months, thin-slice computed tomography) compared.Visual analog scale and oswestry low back pain disability index improved significantly over time (analysis of variance, p<0.001) in both groups, but both scores were significantly better in alif group (analysis of variance, p<0.001).Patients¿ satisfaction consistently ranked higher in the alif group (p=0.042 at 12 mos).No significant difference was found in the fusion rate throughout the study.At final follow-up, 66 patients (82.5%; 34 patients in alif and 32 in aplf group) were available for analysis.One patient died because of a carcinoma of the colon and another because of a carcinoma of the lung.One patient of the alif group had a revision surgery adding posterior stabilization after 1 week.A patient in the alif group presented a clinically asymptomatic dislocation of the synfix-lr cage, together with a breakout of the screws in the surgically treated segment, in a routine radiographic control at 7 days.Reevaluation of the preoperative radiographs and mri revealed a bilateral spondylolysis, which led to implant failure and spondylolisthesis after surgical destabilization.Also, a third patient reported persisting temperature difference between her feet with intermittent paresthesia of the left leg, due to intraoperative damage of the sympathetic nervous system.This report is against a synfix-lr cage regarding temperature fluctuations in lower extremities and paresthesia.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

The device was used for treatment, not diagnosis.This report is for an unknown synfix-lr device with unknown lot number and unknown quantity.(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.

• 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: 4404190
• MDR Text Key: 5433793
• Report Number: 2520274-2015-10084
• 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: 01/09/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention