FDA Adverse Event
Malfunction
Summary report: N
CONDUIT LLIF SQUID INSERTER
MDR report key: 17077030
·
Received June 7, 2023
Report
- Report Number
- 3004641308-2022-00002
- Event Type
- Malfunction
- Date Received
- June 7, 2023
- Date of Event
- August 1, 2022
- Report Date
- June 7, 2023
- Manufacturer
- ENZTEC LIMITED
- Product Code
- MAX
- UDI-DI
- 09421028116459
- PMA / PMN Number
- K220449
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
EXACT DATE OF SURGERY UNKNOWN. EVENT OCCURRED OUTSIDE THE UNITED STATES BUT PRODUCT IS AVAILABLE IN US.
Description of Event or Problem · 0
DURING USE OF THE INSTRUMENT, THE IMPLANT ROTATED UNEXPECTEDLY ANTERIORLY IN THE DISC SPACE SUCH THAT THE IMPLANT HAD TO BE RE-INSERTED DURING THE SAME PROCEDURE. THERE WAS NO DAMAGE TO THE IMPLANT OR INSTRUMENT REPORTED, AND THE DEVICE MECHANISM DOES NOT APPEAR TO HAVE MALFUNCTIONED. THERE WERE NO POST-OPERATIVE COMPLICATIONS REPORTED. INCIDENT OCCURRED IN SWITZERLAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1011715 | CONDUIT LLIF SQUID INSERTER | SPINAL INSERTER | MAX | ENZTEC LIMITED | LET30290T | 09421028116459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | CONDUIT LLIF SQUID BLADE - 22MM. |