FDA Adverse Event
Malfunction
Summary report: N
PIP SZ 20 PROXIMAL
MDR report key: 2472980
·
Received February 16, 2012
Report
- Report Number
- 1651501-2012-00014
- Event Type
- Malfunction
- Date Received
- February 16, 2012
- Date of Event
- December 22, 2011
- Report Date
- February 16, 2012
- Manufacturer
- ASCENSION ORTHOPEDICS
- Product Code
- KYJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING A SURGICAL PROCEDURE TO IMPLANT A RIGHT PROXIMAL INTERPHALANGEAL JOINT, DURING INSERTION OF THE PROXIMAL COMPONENT, THE IMPLANT HEAD BURST INTO SEVERAL PARTS. THE IMPLANT SHAFT WAS STUCK IN THE PROXIMAL PHALANX. THE PROXIMAL PHALANX WAS OPENED WITH A DRILL PROXIMAL TO THE IMPLANT, AND NEW IMPLANT COMPONENTS WERE INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIP SZ 20 PROXIMAL | PIP | KYJ | ASCENSION ORTHOPEDICS | 11-2738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |