FDA Adverse Event
Malfunction
Summary report: N
MANTIS CANNULATED MODULAR TAP 5.5MM
MDR report key: 1203268
·
Received October 14, 2008
Report
- Report Number
- 9617544-2008-00125
- Event Type
- Malfunction
- Date Received
- October 14, 2008
- Date of Event
- September 18, 2008
- Report Date
- September 18, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- HWX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED, AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE HOLE WAS BEING CREATED WITH THE TAP IN THE PEDICLE AND THE TAP BROKE. THE END WAS RETRIEVED AND THE PROCEDURE CONTINUED WITH OUT INCIDENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANTIS CANNULATED MODULAR TAP 5.5MM | INSTRUMENT | HWX | STRYKER SPINE BORDEAUX | NA | 06D131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |