FDA Adverse Event
Other
Summary report: N
ASCENSION CMC SADDLE
MDR report key: 1014116
·
Received March 14, 2008
Report
- Report Number
- 1651501-2008-00006
- Event Type
- Other
- Date Received
- March 14, 2008
- Date of Event
- February 5, 2008
- Report Date
- March 13, 2008
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS SENT TO A PATHOLOGIST FOR STUDY. WE HAVE RECEIVED NO REPORTS YET ON THIS DEVICE.
Description of Event or Problem · 1
SURGEON PERFORMED REVISION ON CMC JOINT DUE TO PAIN ON THE PROXIMAL SIDE. IMPLANT AND TRAPEZIUM WERE REMOVED. THIS REVISION WAS NOT IMPLANT-RELATED. SURGEON NOTED "ON THE SADDLE SIDE OF THE TRAPEZIUM THE BONE LOOKED GREAT". ASCENSION ORTHOPEDICS, INC. ASKS THE SURGEONS RETURN EXPLANTED DEVICES AND BONE SPECIMENS WHEN POSSIBLE. WE THEN EXAMINE THE DEVICES AND BONE, AS A MEANS OF BETTER CHARACTERIZING DEVICE PERFORMANCE AND BETTER UNDERSTANDING OF THE BEHAVIOR OF BONE IN HEMIARTHROPLASTY CONTACT WITH PYROCARBON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION CMC SADDLE | CARPOMETACARPAL (CMC) IMPLANT | KYJ | ASCENSION ORTHOPEDICS, INC. | CMC-410 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |