FDA Adverse Event
Injury
Summary report: N
TORSION ADAPTER
MDR report key: 11054108
·
Received December 22, 2020
Report
- Report Number
- 9615892-2020-00013
- Event Type
- Injury
- Date Received
- December 22, 2020
- Date of Event
- October 23, 2020
- Report Date
- October 30, 2020
- Manufacturer
- OTTO BOCK HEALTHCARE PRODUCTS GMBH
- Product Code
- ISY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
GRADUAL CHANGE OF TORSION RESISTANCE CAUSED BY A LOOSE ADJUSTMENT SCREW DUE TO END OF SERVICE LIFE - SEE IFU "647G23-19-1211" - CHAPTER 4.6 MAINTENANCE INSTRUCTIONS: "AS A BASIC PRINCIPLE, ALL OTTOBOCK MODULAR ADAPTERS ARE SUBJECTED TO TESTS INVOLVING THREE MILLION LOAD CYCLES. DEPENDING ON THE AMPUTEE'S ACTIVITY THIS CORRESPONDS TO A SERVICE LIFE OF THREE TO FIVE YEARS. WE RECOMMEND CARRYING OUT REGULAR SAFETY CHECKS ONCE A YEAR."
Additional Manufacturer Narrative · 1
DEVICE IS CURRENTLY NOT AVAILABLE FOR EVALUATION; SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER EVALUATION OF ALL DEVICE COMPONENTS IS COMPLETED.
Description of Event or Problem · 1
THE TORSION DOESN'T WORKING AND HE FELL DOWN THE STAIRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1521433 | TORSION ADAPTER | EXTERNAL ABOVE KNEE PROSTHESIS | ISY | OTTO BOCK HEALTHCARE PRODUCTS GMBH | 4R85 | 0012201431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R |