FDA Adverse Event
Injury
Summary report: N
ASCENSION MRH
MDR report key: 1142736
·
Received August 26, 2008
Report
- Report Number
- 1651501-2008-00015
- Event Type
- Injury
- Date Received
- August 26, 2008
- Date of Event
- July 21, 2008
- Report Date
- August 26, 2008
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KWI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ASCENSION ORTHOPEDICS IS STILL WAITING ON RESULTS FROM KIDNEY BIOPSY. SUPPLEMENTAL REPORT WILL BE FILED WHEN ADD'L INFO BECOMES AVAILABLE. RE-REVIEW OF MFG AND STERILIZATION RECORDS HAS SHOWN THAT THIS COMPONENT HAS SATISFIED ALL APPLICABLE SPECIFICATIONS.
Description of Event or Problem · 1
PT SUFFERED ACUTE RENAL FAILURE FOLLOWING MRH IMPLANT SURGERY. BIOPSY OF KIDNEY WAS TAKEN IN 2008 TO DETERMINE CAUSE OF EVENT. STILL WAITING FOR BIOPSY RESULTS FROM PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION MRH | MODULAR RADIAL HEAD IMPLANT | KWI | ASCENSION ORTHOPEDICS, INC. | MRH-350 | 07-0041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |