FDA Adverse Event
Malfunction
Summary report: N
SEQUOIA PREBENT ROD, CP TI 35MM
MDR report key: 2081945
·
Received April 5, 2011
Report
- Report Number
- 1649384-2011-00025
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 7, 2011
- Manufacturer
- ZIMMER SPINE
- Product Code
- NKB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNK AND THE MFG RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST-SURGERY, THE RODS CAME OUT OF THE CAPS. THE RODS WERE REPLACED WITH OTHERS OF THE SAME SIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEQUOIA PREBENT ROD, CP TI 35MM | PREBENT ROD | NKB | ZIMMER SPINE | 3313-035 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |