FDA Adverse Event
Injury
Summary report: N
ICELOCK CLUTCH
MDR report key: 761979
·
Received September 13, 2006
Report
- Report Number
- 1836248-2006-00002
- Event Type
- Injury
- Date Received
- September 13, 2006
- Date of Event
- July 18, 2006
- Report Date
- July 19, 2006
- Manufacturer
- OSSUR H/F
- Product Code
- ISS
- PMA / PMN Number
- exempt
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ENGINEERING ANALYSIS IS INCOMPLETE AT THIS TIME. DEVICE IS CURRENTLY FITTED TO AN OSSUR ASSOCIATE IN AN ATTEMPT TO RECREATE THE REPORTED FAILURE. AFTER CLINICAL TESTING IS COMPLETED, THE DEVICE WILL BE DISASSEMBLED TO COMPLETE THE ANALYSIS. DISASSEMBLY IS DEPENDENT ON APPROVAL FROM PT.
Description of Event or Problem · 1
PT WAS WALKING WITH A CO-WORKER AT WORK, TOOK A STEP AND HIS PROSTHETIC LEG FELL BEHIND HIM. REPORTED THAT THE LOCKING DEVICE USED TO CONNECT THE LINER TO THE PROSTHETIC LEG DISCONNECTED. PT FELL RESULTING IN A DISTAL HUMERAL FRACTURE WHICH REQUIRED SURGERY TO REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICELOCK CLUTCH | ISS | ISS | OSSUR H/F | L-214000 | HF050211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| R |