FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON INTERFERENCE SCREW
MDR report key: 1741698
·
Received June 25, 2010
Report
- Report Number
- 9617083-2010-00002
- Event Type
- Malfunction
- Date Received
- June 25, 2010
- Date of Event
- May 19, 2010
- Report Date
- June 18, 2010
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO INSERT THE BONE TAP AND THEREFORE AN ATTEMPT TO INSERT THE SCREW WITHOUT TAPPING WAS MADE. SUSPECTED ROOT CAUSES: FAILURE TO TAP PRIOR TO INSERTION; HARD, DENSE BONE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE SCREW BROKE IN HALF DURING INSERTION. THE DISTAL PART OF THE SCREW WAS REPORTED TO PROVIDE ADEQUATE FIXATION AND REMAINS IN THE PT. THE PROXIMAL HALF OF THE SCREW WAS RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSTEON INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |