FDA Adverse Event
Injury
Summary report: N
ASCENSION NUGRIP
MDR report key: 2030572
·
Received March 18, 2011
Report
- Report Number
- 1651501-2011-00010
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- February 17, 2011
- Report Date
- March 18, 2011
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KYI
- PMA / PMN Number
- K041451
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
X-RAYS WERE SUPPLIED, BUT WERE NOT CONCLUSIVE IN A CAUSE. MFG RECORDS WERE REVIEWED AND DID NOT IDENTIFY WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. IF ADD'L INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
THE SURGEON REPORTED THAT HE WAS REVISING A NUGRIP PROSTHESIS BECAUSE OF REOCCURRING PAIN AND STEM MIGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION NUGRIP | WRIST JOINT CARPAL TRAPEZIUM PROSTHESIS | KYI | ASCENSION ORTHOPEDICS, INC. | THB-442-2010-WW | 08-1534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |