FDA Adverse Event
Injury
Summary report: N
SEG TM COLLAR
MDR report key: 2320571
·
Received October 26, 2011
Report
- Report Number
- 3005751028-2011-00066
- Event Type
- Injury
- Date Received
- October 26, 2011
- Date of Event
- July 11, 2010
- Report Date
- October 26, 2011
- Manufacturer
- ZIMMER TRABECULAR METAL TECHNOLOGY
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S WOUND WOULD NOT HEAL, HE EXPERIENCED PAIN AND HAD DIFFICULTY WITH LIMITED MOTION AND AMBULATION. THE PT WAS DIAGNOSED WITH INFECTION, AND THE IMPLANTS WERE REVIEW TO CORRECT THE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEG TM COLLAR | TM COLLAR | JWH | ZIMMER TRABECULAR METAL TECHNOLOGY | 61432154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |