FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 125°
MDR report key: 4222397
·
Received November 4, 2014
Report
- Report Number
- 0009610622-2014-00622
- Event Type
- Injury
- Date Received
- November 4, 2014
- Date of Event
- October 8, 2014
- Report Date
- October 8, 2014
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- PMA / PMN Number
- K043431
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
INVESTIGATION OF RECEIVED ITEM SHOWED NO SPECIFIC DAMAGE AND IT WAS FULLY FUNCTIONAL ¿ THUS CONCOMITANT ITEM.
Description of Event or Problem · 1
IT WAS REPORTED BY THE HOSPITAL, NON-UNION OF THE FEMORAL NECK. FRACTURE OF THE LAG SCREW. FRACTURE OF THE FEMORAL NECK. GAMMA NAIL. NON-UNION. REVISION SURGERY TO BE PLANNED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE HOSPITAL, NON-UNION OF THE FEMORAL NECK. FRACTURE OF THE LAG SCREW. FRACTURE OF THE FEMORAL NECK. GAMMA NAIL. NON-UNION. REVISION SURGERY TO BE PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708256 | TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 125° | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | STRYKER TRAUMA KIEL | K289464 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Required Intervention |