FDA Adverse Event
Injury
Summary report: N
SPINAL SYSTEM
MDR report key: 2190173
·
Received October 26, 2007
Report
- Report Number
- 3005751028-2007-00051
- Event Type
- Injury
- Date Received
- October 26, 2007
- Date of Event
- August 20, 2007
- Report Date
- October 26, 2007
- Manufacturer
- ZIMMER TMT
- Product Code
- MQP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS.
Description of Event or Problem · 1
ON (B)(6) 2006, A TM 100 WAS IMPLANTED AT THE C4-C5 LEVEL. BECAUSE OF THE REPORTED PAIN A REVISION WAS SCHEDULED ON (B)(6) 2007. THE IMPLANT WAS REPLACED WITH A PEEK IMPLANT AND CAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINAL SYSTEM | HEDROCEL CERVICAL FUSION DEVICE | MQP | ZIMMER TMT | 113081-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |