FDA Adverse Event
Other
Summary report: N
CALAXO UNKNOWN SCREW SIZE
MDR report key: 1060710
·
Received June 12, 2008
Report
- Report Number
- 1219602-2008-00148
- Event Type
- Other
- Date Received
- June 12, 2008
- Report Date
- May 12, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT RECALL INITIATED IN 2007.
Description of Event or Problem · 1
PATIENT EXPERIENCED POST-OP CONDITION AND HAD A REVISION SURGERY TO REMOVE THE CALAXO SCREW. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO UNKNOWN SCREW SIZE | CALAXO SCREW | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIV. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |