FDA Adverse Event
Injury
Summary report: N
PASS LP
MDR report key: 2696108
·
Received December 23, 2011
Report
- Report Number
- 1000432246-2011-00012
- Event Type
- Injury
- Date Received
- December 23, 2011
- Date of Event
- October 27, 2011
- Report Date
- November 29, 2011
- Manufacturer
- MEDICREA INTERNATIONAL
- Product Code
- MNI
- PMA / PMN Number
- K083810
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION: DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. CONCLUSION: NO CONCLUSION COULD BE DONE AS INSUFFICIENT INFORMATION HAS BEEN PROVIDED. ADDITIONAL PMA/510(K) # K080099.
Description of Event or Problem · 1
FIRST CONTROL ON (B)(6) WAS CONFORM. DURING 4 MONTH POST-OP (B)(6), BROKEN ROD WAS DETECTED ON RIGHT SIDE. REVISION HAS BEEN PLANNED FOR (B)(6) 2011. DURING REVISION, CONNECTOR HAS BEEN FOUND TO BE BROKEN TOO BUT ON THE OTHER SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PASS LP | PEDICLE SCREW | MNI | MEDICREA INTERNATIONAL | 10I0387 / 09B0071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |