FDA Adverse Event
Other
Summary report: N
BILOK SCREW
MDR report key: 1310508
·
Received February 11, 2009
Report
- Report Number
- 9617083-2009-00001
- Event Type
- Other
- Date Received
- February 11, 2009
- Date of Event
- January 5, 2009
- Report Date
- January 30, 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
FROM THE INFORMATION AVAILABLE THE REASON FOR THE INFLAMMATORY RESPONSE HAS NOT BEEN IDENTIFIED.
Description of Event or Problem · 1
PATIENT HAD ACL RECONSTRUCTION (B)(6)2008. REPORTED SWELLING OF KNEE (B)(6)2008. NO INFECTION, SUSPECTED INFLAMMATORY RESPONSE. PATIENT PRESCRIBED ANTIBIOTICS. WOUND APPEARED TO BREAKDOWN. ACL SCREW EXPLANTED (B)(6)2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BILOK SCREW | ACL SCREW | HWC | BIOCOMPOSITES LTD. | BILOK SCREW | 11/06-PT811 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |