|
Device Problem
Unintended Movement (3026)
|
Patient Problems
Failure of Implant (1924); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
510k: this report is for an unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients who underwent surgical procedures for early onset scoliosis that include device lengthening, revision, removal, and spinal fusion.Based on the retrospective data review of historically treated patients, the following have been identified as the reported complications: 1 patient had implant migration.33 patients had implant breakage (broken rods).24 patients had a loss of fixation.1 patient had iliac prominence.1 patient had sacral screws lucency.This is for depuy spine expedium 4.5 with extended tandem connector.This complaint involves six (6) devices.This report is for (1) unknown screw.This is report 5 of 6 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|