FDA Adverse Event
Malfunction
Summary report: N
CERVICAL DOWEL INSTRUMENT
MDR report key: 801463
·
Received December 22, 2006
Report
- Report Number
- 2246640-2006-00008
- Event Type
- Malfunction
- Date Received
- December 22, 2006
- Date of Event
- November 2, 2006
- Report Date
- November 27, 2006
- Manufacturer
- OSTEOTECH, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RETURNED INSTRUMENT WAS EVALUATED. ONE OF TWO PINS DESIGNED TO INTERFACE WITH THE GRAFT WAS SHEARED OFF.
Description of Event or Problem · 1
DURING THE PROCEDURE, THE SURGEON WAS INSERTING THE BONE GRAFT AND TWISTING AND RETRACTNG. ONE OF THE TWO PRONGS AT THE GRAFT/INSTRUMENT INTERFACE THEN BROKE OFF IN THE GRAFT. THE SURGEON REMOVED THE BROKEN PRONG FROM THE GRAFT AND DISCARDED IT. THE GRAFT WAS LEFT IN PLACE, AS IT WAS ALREADY FULLY INSERTED. NO DELAY IN SURGERY WAS REPORTED. PATIENT CONDITION IS FINE WITH NO REPORT OF INJURY RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERVICAL DOWEL INSTRUMENT | ORTHOPEADIC SURGICAL INSTRUMENT | LXH | OSTEOTECH, INC. | * | TROS01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | CERVICAL DOWEL BONE GRAFT (11MM) |