Catalog Number 3505-7540 |
Device Problem
Disassembly (1168)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
|
|
Event Description
|
It was reported that a pedicle screw disassembled during surgery.During the procedure, the surgeon backed out a pedicle screw to change its position.After removal, the tulip head detached from the screw shaft.The procedure was completed using an alternative screw.There was no report of patient impact associated with this event.
|
|
Manufacturer Narrative
|
The returned screw was evaluated.The tulip was found disassembled from the shaft as reported.The retention ring was found to be deformed.The cause is likely attributed to final locking and subsequent loosening of the screw in order to change positions since the screw disassembled while the position was being adjusted.A review of the manufacturing records did not identify any issues which would have contributed to this event.
|
|
Search Alerts/Recalls
|