FDA Adverse Event
Injury
Summary report: N
LOCKING SCREW, FULLY THREADED 5X30 MM
MDR report key: 2221611
·
Received August 19, 2011
Report
- Report Number
- 9610622-2011-00380
- Event Type
- Injury
- Date Received
- August 19, 2011
- Date of Event
- July 18, 2011
- Report Date
- July 29, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K021026
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS ALSO REPORTED THAT THE PT RECEIVED THE ORIGINAL NAIL ABOUT 14 MONTHS AGO. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED BY THE HOSPITAL. IF ADD'L INFO BECOMES AVAILABLE, THEN, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT ACCORDING TO THE SURGEON, THE PT PRESENTED WITH A FRACTURED GAMMA SCREW. IT WAS REPORTED THAT THE PT WAS CONVERTED TO A TOTAL HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW, FULLY THREADED 5X30 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K287119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |