FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 2783918
·
Received October 3, 2012
Report
- Report Number
- 9617083-2012-00028
- Event Type
- Malfunction
- Date Received
- October 3, 2012
- Date of Event
- September 7, 2012
- Report Date
- October 2, 2012
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUSPECTED ROOT CAUSE: RESISTANCE TO INSERTION WAS VERY HIGH AND THE APPLIED TORQUE EXCEEDED THE TORSIONAL STRENGTH OF THE SCREW.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A SURGERY, WHILE TIGHTENING, THE SCREW FRACTURED IN THE MIDDLE AND THE THREADED END REMAINED IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. | 0412PH303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |