FDA Adverse Event
Malfunction
Summary report: N
TX IBF SYSTEM
MDR report key: 19996683
·
Received August 15, 2024
Report
- Report Number
- 3004719693-2024-00001
- Event Type
- Malfunction
- Date Received
- August 15, 2024
- Date of Event
- August 8, 2024
- Manufacturer
- INNOVASIS, INC.
- Product Code
- MAX
- UDI-DI
- M711LS39707050
- PMA / PMN Number
- K180078
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
PER SYSTEM DFMEA THE FOLLOWING LINE ITEMS MAY APPLY: "INSTRUMENT BREAKAGE/DAMAGE" MAY LEAD TO "CUSTOMER DISSATISFACTION, SURGICAL DELAY" "TRIAL IMPLANTED" MAY LEAD TO "FAILED FUSION, IMPLANT MIGRATION, PAIN, SURGICAL DELAY, REVISION SURGERY." FOR THIS SPECIFIC CASE, THE ONLY EFFECT ON THE PATIENT THUS FAR HAS BEEN SURGICAL DELAY. IMPLANTING THE TRIAL IMPLANT IS CONSIDERED OFF-LABEL USE THEREFORE THE CUSTOMER IS ADVISED TO MONITOR FOR ANY ADVERSE EFFECTS.
Description of Event or Problem · 0
DURING SURGERY, A TX TRIAL LS-397 BROKE OFF OF THE INSERTER LS-395. THE TRIAL WAS LEFT IMPLANTED IN THE PATIENT INSTEAD OF BEING REPLACED WITH THE INTENDED CAGE, AND GRAFT WAS PACKED AROUND IT. THE SURGEON DID NOT WANT TO TRY AND REMOVE THE STUCK TRIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 992399 | TX IBF SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT | MAX | INNOVASIS, INC. | LS-397-0705 | M711LS39707050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |