FDA Adverse Event
Injury
Summary report: N
ABGII MODULAR SHORT NECK
MDR report key: 2850913
·
Received November 20, 2012
Report
- Report Number
- 9616680-2012-01148
- Event Type
- Injury
- Date Received
- November 20, 2012
- Date of Event
- October 22, 2012
- Report Date
- October 26, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K092406
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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
THE SURGEON AT THE CLINIC, REPORTED TO THE OPERATIVE ASSISTANT, THAT "A REVISION SURGERY WAS PERFORMED ON (B)(6) 2012, BECAUSE AN ADVERSE REACTION TO CHROME COBALT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABGII MODULAR SHORT NECK | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | G3079920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other| R |