FDA Adverse Event
Malfunction
Summary report: N
CERVICAL DOWEL INSTRUMENT SET
MDR report key: 829233
·
Received October 27, 2006
Report
- Report Number
- 2246640-2006-00006
- Event Type
- Malfunction
- Date Received
- October 27, 2006
- Date of Event
- September 26, 2006
- Report Date
- September 27, 2006
- Manufacturer
- OSTEOTECH, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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
SURGEON HAD COMPLETED PREPARING THE ENDPLATES FOR THE PLACEMENT OF THE BONE GRAFT. AFTER HAVING SECURED THE BONE GRAFT INTO PLACE, THE SURGEON BEGAN TO DISENGAGE THE INSERTER INSTRUMENT AT WHICH POINT ONE OF THE TWO PRONGS BROKE FROM THE BASE OF THE INSERTER. THE BONE GRAFT REMAINED SECURE AND COMPLETE TO THE SURGEON'S APPROVAL. THE BROKEN PRONG REMAINED IN THE BONE GRAFT AND WAS READILY REMOVED FROM THE BONE GRAFT AND PROPERLY DISPOSED. SURGERY WAS NOT SIGNIFICANTLY ALTERED AND NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERVICAL DOWEL INSTRUMENT SET | ORTHOPEDIC SURGICAL INSTRUMENT SET | LXH | OSTEOTECH, INC. | * | 004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | CERVICAL DOWEL BONE GRAFT (13MM) |