FDA Adverse Event
Malfunction
Summary report: N
CANNULATED COMPRESSION SCREW
MDR report key: 2181128
·
Received July 8, 2011
Report
- Report Number
- 8010177-2011-00198
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- May 26, 2011
- Report Date
- June 17, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HRS
- PMA / PMN Number
- K013775
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCREW WAS IMPLANTED ON (B)(6) 2011. ON (B)(6) 2011 (APPROX), WHEN THE PT FELL DOWN AND LANDED ON HIS HANDS, THE PARTS OF BLUE SITE AND YELLOW SITE WERE SEPARATED. THE SCREW WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED COMPRESSION SCREW | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |