FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 3959127
·
Received May 20, 2014
Report
- Report Number
- 9617083-2014-00019
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 4, 2014
- Report Date
- April 22, 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
BASED ON THE INFORMATION AVAILABLE, POSSIBLE SUSPECTED ROOT CAUSE(S): 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 A BIOSTEON SCREW BROKE DURING INSERTION. THERE WAS NO IMPACT ON THE PATIENT, NO MEDICAL INTERVENTION REQUIRED, NO ADVERSE CONSEQUENCES, NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298945 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. | 0913PH298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |