FDA Adverse Event
Other
Summary report: N
IMPIX TLIF
MDR report key: 2287372
·
Received October 4, 2011
Report
- Report Number
- 1000432246-2011-00005
- Event Type
- Other
- Date Received
- October 4, 2011
- Report Date
- June 7, 2011
- Manufacturer
- MEDICREA INTERNATIONAL
- Product Code
- MAX
- PMA / PMN Number
- K083798
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION: DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. ADDITIONAL INFO HAS BEEN REQUESTED TO INVESTIGATE THE ADVERSE EVENT. CONCLUSION: NO CONCLUSION CAN BE MADE AS INSUFFICIENT INFO HAS BEEN PROVIDED. BROKEN DEVICE WAS NOTED ON X/RAY POST-OPERATIVELY. NO INTERVENTION HAS BEEN REQUIRED NOR HAS THE PT EXHIBITED ANY NEGATIVE EFFECTS BECAUSE OF THE BROKEN DEVICE.
Description of Event or Problem · 1
IN (B)(6) 2011, DISTRIBUTOR REPORTS ONE CASE OF BROKEN CAGE DETECTED POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPIX TLIF | INTERVERTEBRAL BODY FUSION DEVICE | MAX | MEDICREA INTERNATIONAL | 10C0336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |