FDA Adverse Event
Injury
Summary report: N
UNKNOWN TM SPINE IMPLANT
MDR report key: 4181476
·
Received August 28, 2014
Report
- Report Number
- 3005751028-2014-00061
- Event Type
- Injury
- Date Received
- August 28, 2014
- Date of Event
- March 29, 2007
- Report Date
- August 28, 2014
- Manufacturer
- ZIMMER TMT
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED DURING A RETROSPECTIVE STUDY, THE DOCTOR OBSERVED NON-UNION OF THE UNK TM SPINE IMPLANT AT LEVEL C5-C6 FOLLOWING 2 YEARS AFTER INDEX OPERATION. IT WAS NOTED THAT THE PT DID NOT WANT TO RECEIVE FURTHER SURGERY AND THAT THERE WAS LITTLE SYMPTOMATIC IMPACT. THIS PT IS PARTICIPATING IN A (B)(4) STUDY, BUT THE ADVERSE EVENT WAS OBSERVED PRIOR TO THE STUDY INITIATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523877 | UNKNOWN TM SPINE IMPLANT | UNK TM SPINE IMPLANT | KWA | ZIMMER TMT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |