MAUDE Adverse Event Report: DEPUY-SYNTHES SYNFIX LR; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION

Model Number 03.802

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Arthritis (1723)

Event Date 08/01/2004

Event Type  Injury  

Event Description

Literature reports from (b)(6) 2004 until (b)(6) 2007, 95 pts (21 double-level and 74 single-level) with degenerative disk disease from l3-s1 were operated by a single surgeon.The number of reoperations was counted, 26 pts were reoperated after a median period of 17.6 months (range 6.7-46.9) of the initial surgery.Of the 26 pts, 23 pts (18 single-level and 5 double-level) were reoperated for symptomatic pseudarthrosis.A high number of reoperations after an anterior lumbar interbody fusion procedure with the synfix-lr cage were found, mainly because of symptomatic pseudarthrosis.The absence of posterior fixation in combination with lower stiffness and the hydrophobic characteristics of peek probably lead to insufficient initial stability, creating suboptimal conditions for bony bridging, and thus solid fusion.The proposed ease of the eval of radiologic fusion could not be supported.Clinicians should be alert on pseudarthrosis when pts treated with the synfix-lr cage presented with persisted or aggravated complaints schimmel, janneke jp, et al."peek cages in lumbar fusion: mid-term clinical outcome and radiologic-fusion." clinical spine surgery 29.5 (2016): e252-e258.

• Brand Name: SYNFIX LR
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION
• Manufacturer (Section D): DEPUY-SYNTHES
• MDR Report Key: 7040879
• MDR Text Key: 92528128
• Report Number: MW5073390
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/15/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: 03.802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 73