FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 3959119
·
Received May 20, 2014
Report
- Report Number
- 9617083-2014-00020
- 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 ROOD CAUSES(S): USE OF DAMAGED OR BEND DRIVER; GRAFT/SCREW/TUNNEL NOT APPROPRIATELY SIZED; INSERTION OVER BENT GUIDEWIRE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT FOLLOWING A BIOSTEON SCREW BREAKING DURING INSERTION, AS SECOND BIOSTEON SCREW BROKE IN SUCCESSION IN THE SAME SURGERY. 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 |
|---|---|---|---|---|---|---|---|
| 298988 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. | 0913PJ298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |