FDA Adverse Event
Other
Summary report: N
BIOSTEON SCREW
MDR report key: 731826
·
Received July 5, 2006
Report
- Report Number
- 9617083-2006-00002
- Event Type
- Other
- Date Received
- July 5, 2006
- Date of Event
- June 5, 2006
- Report Date
- June 30, 2006
- Manufacturer
- BIOCOMPOSITES LTD
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO COMPLICATIONS WERE REPORTED DURING THE SURGERY. THE SCREW WAS REMOVED BECAUSE IT CAME LOOSE. THERE WAS ALSO A SLIGHT INFECTION. THE ACL WAS INTACT AND THE SCREW WAS INTACT WHEN IT WAS REMOVED.
Description of Event or Problem · 1
SCREW REMOVED AS IT HAD BECOME LOOSE. INFECTION ALSO PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSTEON SCREW | ACL SCREW | HWC | BIOCOMPOSITES LTD | * | 07/05-PH286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |