FDA Adverse Event
Injury
Summary report: N
2520274-2013-05841
MDR report key: 3317884
·
Received August 29, 2013
Report
- Report Number
- 2520274-2013-05841
- Event Type
- Injury
- Date Received
- August 29, 2013
- Report Date
- July 31, 2013
- Manufacturer
- SYNTHES, USA
- Product Code
- KTT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
JOURNAL ARTICLE RECEIVED: RADIOGRAPHIC AND FUNCTIONAL RESULTS OF OSTEOSYNTHESIS USING THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES; SAHIN S., ERTURER E., OZTURK I., TOKER S., SECKIN F., AKMAN S.; ACTA ORTHOPAEDICA ET TRAUMATOLOGICA TURCICA. (2010); 44 (2):127-134 REPORTED: SECONDARY VARUS WAS IDENTIFIED IN TWO PATIENTS ON FINAL RADIOGRAPHS. DEVICE WAS REPORTED AS SYNTHES PRODUCT. THIS IS 2 OF 4 FOR UNKNOWN NAIL FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 425196 | KTT | SYNTHES, USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |