FDA Adverse Event
Other
Summary report: N
BILOK SCREW
MDR report key: 1321124
·
Received February 23, 2009
Report
- Report Number
- 9617083-2009-00003
- Event Type
- Other
- Date Received
- February 23, 2009
- Date of Event
- December 30, 2008
- Report Date
- February 13, 2009
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K003641
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TRAUMATIC SPORTING INJURY LED TO FAILED ACL GRAFT RECONSTRUCTION AND REMOVAL OF GRAFT AND FIXATION SCREWS. A SEPARATE MDR IS FILED FOR THE BILOK SCREW USED IN THE SAME PROCEDURE.
Description of Event or Problem · 1
PT HAD ACL RECONSTRUCTION (B)(6)2007. PT HAD TRAUMATIC INJURY WHILE PLAYING SOCCER ON (B)(6)2008. ACL SCREW EXPLANTED (B)(6)2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BILOK SCREW | ACL SCREW | HWC | BIOCOMPOSITES LTD. | BILOK ST SCREW | 10/05-PT410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |