FDA Adverse Event
Malfunction
Summary report: N
PSI 120 120 40 PEEK
MDR report key: 2306030
·
Received September 26, 2011
Report
- Report Number
- 2520274-2011-00598
- Event Type
- Malfunction
- Date Received
- September 26, 2011
- Report Date
- August 29, 2011
- Product Code
- GXN
- PMA / PMN Number
- K033868
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
DEVICE REPORT FROM (B)(4) REPORTED AN INCORRECT FIT OF A PT SPECIFIC IMPLANT, DEVICE WAS MISSING A DRILL-HOLE. SURGEON IS CONSIDERING A POSSIBLE REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PSI 120 120 40 PEEK | PSI 120 120 40 PEEK | GXN | 3802337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |