FDA Adverse Event
Malfunction
Summary report: N
OBWEGESER SPLITT OSTEOTOME, 8MM, 22CM
MDR report key: 1841222
·
Received September 20, 2010
Report
- Report Number
- 8010177-2010-00326
- Event Type
- Malfunction
- Date Received
- September 20, 2010
- Date of Event
- August 18, 2010
- Report Date
- August 23, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION RESULT SHOWS THAT THE DEFORMATIONS AND THE BREAKAGE OF THE OSTEOTOME WERE CAUSED BY HIGH BENDING LOADS DURING SURGERY. THEREFORE, THE INVESTIGATED FAILURE IS ATTRIBUTED TO INAPPROPRIATE USER HANDLING. CONSIDERING THE TECHNICAL INVESTIGATION RESULTS THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. BASED ON THE STATISTICAL EVALUATION NO INDICATION WAS FOUND FOR ANY DEVICE RELATED ISSUE.
Description of Event or Problem · 1
JAW PART OF OSTEOTOME WAS BROKEN DURING SURGERY USING PROCEDURE AFTER CUTTING MANDIBLE PART WITH STRYKER SAW EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBWEGESER SPLITT OSTEOTOME, 8MM, 22CM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS FREIBURG | NA | Z8-08/09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |