FDA Adverse Event
Malfunction
Summary report: N
IDYS-TLIF TIVAC
MDR report key: 9655858
·
Received January 31, 2020
Report
- Report Number
- 3009962553-2019-00009
- Event Type
- Malfunction
- Date Received
- January 31, 2020
- Date of Event
- November 7, 2019
- Report Date
- December 5, 2019
- Manufacturer
- CLARIANCE SAS
- Product Code
- MAX
- UDI-DI
- 03700780628643
- PMA / PMN Number
- K183259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE SURGERY WAS EXTENDED BY 35 MINUTES AS A RESULT OF THE CAGE BREAKAGE.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119184 | IDYS-TLIF TIVAC | TLIF CAGE | MAX | CLARIANCE SAS | 41532909-S | 03700780628643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female |