FDA Adverse Event
Other
Summary report: N
TROCHANTERIC NAIL KIT, STST ?11X180MM X 125?
MDR report key: 1346797
·
Received March 17, 2009
Report
- Report Number
- 9610622-2009-00082
- Event Type
- Other
- Date Received
- March 17, 2009
- Date of Event
- February 23, 2009
- Report Date
- February 23, 2009
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K043431
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THE FOLLOWING BY LETTER: "THE OR DEPARTMENT REPORTED THE FOLLOWING, THERE WAS NO SET SCREW IN THE KIT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, STST ?11X180MM X 125? | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K986085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |