FDA Adverse Event
Injury
Summary report: N
ABGII MODULAR SHORT NECK
MDR report key: 2870009
·
Received December 4, 2012
Report
- Report Number
- 9616680-2012-01263
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 9, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- KWY
- PMA / PMN Number
- K092406
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HIP PAIN SO THE SURGEON REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABGII MODULAR SHORT NECK | IMPLANT | KWY | STRYKER ORTHOPAEDICS CORK | NA | G3005814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other| R |