FDA Adverse Event
Injury
Summary report: N
SEQUOIA NON-CANNULATED BONE TAP 6.5MM
MDR report key: 2894145
·
Received December 27, 2012
Report
- Report Number
- 1649384-2012-00127
- Event Type
- Injury
- Date Received
- December 27, 2012
- Date of Event
- September 11, 2012
- Report Date
- December 7, 2012
- Manufacturer
- ZIMMER SPINE
- Product Code
- KWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
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. BASED ON THE REPORTED INFO THERE IS NOT ANY EVIDENCE OF PRODUCT FAILURE CONTRIBUTING TO THE REPORTED PROBLEM. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADD'L ACTION IS REQUIRED AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE SURGEON WAS PREPARING THE BONE WITH THE 6.5MM BONE TAP, THE TAP SLIPPED. THE DURA METER OF THE PATIENT WAS DAMAGED. THE DURA METER WAS REPAIRED AND NOT ADD'L IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEQUOIA NON-CANNULATED BONE TAP 6.5MM | SEQUOIA NON-CANNULATED BONE TAP 6.5MM | KWQ | ZIMMER SPINE | 3361-065 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |