FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 4201314
·
Received September 17, 2014
Report
- Report Number
- 9617083-2014-00035
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Date of Event
- August 7, 2014
- Report Date
- August 13, 2014
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BATCH MANUFACTURING RECORD WAS REVIEWED AND NO CONTRIBUTORY FACTORS WERE IDENTIFIED. BASED ON THE INFORMATION AVAILABLE, POSSIBLE SUSPECTED ROOT CAUSES: FAILURE TO TAP/USE DILATOR, USE OF DAMAGED OR BENT DRIVER, GRAFT/SCREW/TUNNEL NOT APPROPRIATELY SIZED, INSERTION OVER BENT GUIDEWIRE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 7 X 28MM BIOSTEON SCREW BROKE DURING SURGERY. SURGERY DETAILS WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577112 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |