FDA Adverse Event
Other
Summary report: N
CALAXO 7X25MM REVERSE THREAD SCREW
MDR report key: 1010138
·
Received March 10, 2008
Report
- Report Number
- 1219602-2008-00054
- Event Type
- Other
- Date Received
- March 10, 2008
- Report Date
- February 6, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PROD RECALL INITIATED AUGUST 21, 2007.
Description of Event or Problem · 1
SURGEON REPORTED HE HAS A PT WHO IS 7 MONTHS S/P LEFT KNEE RECONSTRUCTION AND HAS COMPLAINTS OF A SYMPTOMATIC CYST WHICH WAS CONFIRMED ON MRI. THE PT WILL NEED TO HAVE SURGERY TO REMOVE HER CYST AND LIKELY BONE-GRAFT HER DEFECT. HOWEVER, HER ACL IS DOING VERY WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO 7X25MM REVERSE THREAD SCREW | CALAXO SCREW | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7211114 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |