FDA Adverse Event
Malfunction
Summary report: N
PASS LP
MDR report key: 12379737
·
Received August 27, 2021
Report
- Report Number
- 1000432246-2021-00009
- Event Type
- Malfunction
- Date Received
- August 27, 2021
- Date of Event
- March 3, 2017
- Report Date
- August 27, 2021
- Manufacturer
- MEDICREA INTERNATIONAL
- Product Code
- MNI
- PMA / PMN Number
- K140738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PRESENTATION OF A SCIATIC IN L5: MALPOSITIONNED SCREW IN S1 OBSERVED ON A SCAN + ROD TOO LONG RISK OF PJK. REOPERATION TO REMOVE THE S1 SCREWS AND TO ADD SOME SUBLAMAR BANDS ON T2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1277821 | PASS LP | UNID ROD | MNI | MEDICREA INTERNATIONAL | B33226012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |