FDA Adverse Event
Injury
Summary report: N
BIO-PREP BONE PREPARATION KIT
MDR report key: 1517307
·
Received October 19, 2009
Report
- Report Number
- 2648666-2009-00247
- Event Type
- Injury
- Date Received
- October 19, 2009
- Date of Event
- September 22, 2009
- Report Date
- September 22, 2009
- Manufacturer
- STRYKER INSTRUMENTS PUERTO RICO
- Product Code
- JDK
- PMA / PMN Number
- K931847
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR FOR INVESTIGATION. NO ADD'L INFO WAS RECEIVED BY THE FACILITY DESPITE NUMEROUS ATTEMPTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BONE PLUG INSERTER BROKE OFF INSIDE THE PT'S FEMORAL CANAL. IT IS UNK IF THE PIECES WERE RETRIEVED OR IF THE PT REQUIRED ADD'L TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-PREP BONE PREPARATION KIT | PROTHESIS, HIP, CEMENT RESTRICTOR | JDK | STRYKER INSTRUMENTS PUERTO RICO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |