FDA Adverse Event
Injury
Summary report: N
HELICAL BLADE
MDR report key: 2921581
·
Received January 18, 2013
Report
- Report Number
- 2520274-2013-00431
- Event Type
- Injury
- Date Received
- January 18, 2013
- Report Date
- December 20, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- KTT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH TFN, HELICAL BLADE, AND SCREW CONSTRUCT ON UNKNOWN DATE. ON UNKNOWN DATE, PATIENT RETURNED TO THE OR AND ALL HARDWARE WAS REMOVED DUE TO PATIENT BEING DIAGNOSED WITH POOR BONE QUALITY AND POOR BLOOD SUPPLY TO THE FEMORAL HEAD. PATIENT WAS REVISED WITH TOTAL HIP REPLACEMENT. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27658 | HELICAL BLADE | KTT | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | NAIL, SCREW |