FDA Adverse Event
Other
Summary report: N
CALAXO UNKNOWN
MDR report key: 1038757
·
Received May 1, 2008
Report
- Report Number
- 1219602-2008-00115
- Event Type
- Other
- Date Received
- May 1, 2008
- Report Date
- March 31, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIVISION
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT RECALL INITIATED IN 2007.
Description of Event or Problem · 1
PATIENT PRESENTED POST-OP CONDITION WITH INFLAMMATORY RESPONSE 6 MONTHS AFTER ACL SURGERY AND HAD TO REMOVE THE SCREW. THE GRAFT IS FINE, SURGEON USED A HAMSTRING GRAFT WITH A BACK-UP FIXATION TYING THE SUTURES OVER A SCREW. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO UNKNOWN | CALAXO SCREW | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |