|
Device Problem
Device Slipped (1584)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 01/01/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional narrative: 510k: this report is for an unknown rod/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.510k: this report is for an unknown rod/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Reporter is a j&j sales representative.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
|
It was reported that on an (b)(6) 2022 ,the patient underwent revision surgery due to loosening of rod/set screw.The rod loosens within the tulip head.Patient and procedure outcome were unknown.This report is related to (b)(4) which captures the reported event of patient requiring 3rd surgery as the rod has once again migrated in the tulip head.This is report 3 of 3 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|