FDA Adverse Event
Other
Summary report: N
CALAXO - UNKNOWN
MDR report key: 1023737
·
Received March 28, 2008
Report
- Report Number
- 1219602-2008-00082
- Event Type
- Other
- Date Received
- March 28, 2008
- Report Date
- March 3, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT RECALL INITIATED 2007.
Description of Event or Problem · 1
PATIENT PRESENTED WITH POST-OP TIBIAL PAIN AND IMPLANTS FEELING AS THROUGH THEY ARE "BACKING OUT". SURGEON DESCRIBED THE X-RAY AS THE IMPLANTS LOOKED LIKE "TWO HORNS" HAS FORMED. SURGEON PERFORMS DOUBLE BUNDLE TECHNIQUE AND ROUTINELY USED TWO CALAXO SCREWS IN THE TIBIA. IT IS NOT KNOWN AT THIS TIME IF PT HAS HAD FOLLOW-UP SURGERY. ORIGINAL SURGERY DATE WAS 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO - UNKNOWN | CALAXO SCREW | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIV. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |