Model Number RA002-5555SL |
Device Problem
Defective Device (2588)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 11/09/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
No product has been returned for evaluation.Evaluation was performed by london implant retrieval center (lirc).
|
|
Event Description
|
Information was received that a revision procedure was performed on (b)(6) 2016.As per reporter the rods were removed for final fusion.During service a pin fracture was identified.
|
|
Event Description
|
Information was received that a revision procedure was performed on (b)(6) 2016 for final fusion.During a review of investigation findings from lirc it was identified that the rod had failed to distract.No other information in relation to patient has been reported.
|
|
Search Alerts/Recalls
|