FDA Adverse Event
Injury
Summary report: N
REJUVENATE MODULAR NECK
MDR report key: 2901588
·
Received January 3, 2013
Report
- Report Number
- 9616680-2012-01541
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- June 1, 2010
- Report Date
- December 7, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
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 PATIENT HAS STIFFNESS, ACHINESS, SWELLING, AND LIMITED RANGE OF MOTION. ADDITIONAL EVENT DESCRIPTION SUBMITTED BY SALES REP - (B)(6) 2012: IT WAS REPORTED THAT THE COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3263 | REJUVENATE MODULAR NECK | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 26963802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other| R |