FDA Adverse Event
Injury
Summary report: N
ASCENSION PIP
MDR report key: 2030567
·
Received March 18, 2011
Report
- Report Number
- 1651501-2011-00012
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- January 11, 2011
- Report Date
- March 18, 2011
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- NEG
- PMA / PMN Number
- H010005
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
X-RAYS WERE SUPPLIED, BUT SHOWED THE DISTAL COMPONENT WAS NOT FRACTURED. AN EVALUATION OF THE RETURNED COMPONENTS WAS COMPLETED. THE FRACTURE OF THIS COMPONENT MAY BE DUE TO REMOVAL OR MISHANDLING. IF ADD'L INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED AS APPROPRIATE. CONCLUSIONS: HEAD-STEM FRACTURES, AS OBSERVED IN THE SIZE 20 PROXIMAL COMPONENT, ARE KNOWN TO OCCUR AS A RESULT OF SURGICALLY IMPACTING AN UNSUPPORTED HEAD AS A RESULT OF IMPROPER OBLIQUE OSTEOTOMY PREPARATION.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT A PT IN (B)(6) HAD A PROXIMAL COMPONENT FRACTURED. AN X-RAY THAT WAS SUPPLIED CONFIRMED THIS OBSERVATION. WHEN THE DEVICE WAS RETURNED AN ADD'L FRACTURED PROXIMAL COMPONENT WAS RETURNED ALONG WITH A FRACTURED DISTAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP | FINGER PYROLYTIC CARBON PROSTHESIS | NEG | ASCENSION ORTHOPEDICS, INC. | PIP-200-20D-WW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |