FDA Adverse Event
Injury
Summary report: N
BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X8MM,(5/PACKAG
MDR report key: 1895479
·
Received November 5, 2010
Report
- Report Number
- 8010177-2010-00420
- Event Type
- Injury
- Date Received
- November 5, 2010
- Date of Event
- September 23, 2010
- Report Date
- October 14, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K022185
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED VIA OUR DISTRIBUTOR THAT THE 2 SCREW BROKE WHILST IMPLANTED. IT IS FURTHER REPORTED THAT THE HEADS WERE RETRIEVED BUT THE SHAFT OF BOTH SCREWS ARE LEFT IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X8MM,(5/PACKAG | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | L7500F0F02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |