MalfunctionMAX
IDYS-TLIF TIVAC
Received Jan 31, 2020 · Event occurred Nov 7, 2019
Report 3009962553-2019-00009 · MDR key 9655858
Device
Product problems
- Break
- Break
Patient
77 YR · Female
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SURGERY WAS EXTENDED BY 35 MINUTES AS A RESULT OF THE CAGE BREAKAGE.
Description of Event or Problem
THE TLIF CAGE BROKE WHEN BEING MANEUVERED INTO POSITION AFTER THE CAGE WAS INITIALLY INSERTED THROUGH THE ANTERIOR PORTION OF THE DISC. IT WAS REPORTED THAT THE CAGE SHEERED OFF IN HALF AS THE SURGEON WAS PULLING BACK ON THE INSERTER. AFTER SEVERAL ATTEMPTS, THE 2 PIECES WERE REMOVED. A SECOND CAGE WAS SUCCESSFULLY INSERTED. NO PATIENT HARM WAS REPORTED AND THE SURGERY WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT.
Remedial action
- Replace