FDA Adverse Event
Injury
Summary report: N
PASS LP
MDR report key: 1571536
·
Received January 4, 2010
Report
- Report Number
- 1000432246-2010-00001
- Event Type
- Injury
- Date Received
- January 4, 2010
- Date of Event
- December 7, 2009
- Report Date
- January 4, 2010
- Manufacturer
- MEDICREA TECHNOLOGIES
- Product Code
- MNI
- PMA / PMN Number
- K080099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATIONS: THE IMPLANT WAS NOT AVAILABLE FOR EVALUATION. THE SURGICAL TECHNIQUE WAS NOT FOLLOWED AS THE SCREWS WERE NOT BICORTICAL PER THE INSTRUCTIONS IN THE SURGICAL TECHNIQUES. CONCLUSIONS: BACK OUT OF THE SCREWS ARE POSSIBLE UNDESIRABLE EFFECTS WHICH ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. THE REPORTED INCIDENT IS NOT A PRODUCT RELATED FAILURE AND DOES NOT QUESTION THE EFFICACY OF THE PASS LP SYSTEM.
Description of Event or Problem · 1
IN 2009, SALES REP REPORT 1 CASE OF BACK OUT OF SACRAL SCREW (S2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PASS LP | SACRAL SCREW | MNI | MEDICREA TECHNOLOGIES | B02157235 | 08D0081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |