MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-09-13 for ICELOCK CLUTCH L-214000 manufactured by Ossur H/f.
[18338910]
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.
Patient Sequence No: 1, Text Type: D, B5
[18390408]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836248-2006-00002 |
| MDR Report Key | 761979 |
| Report Source | 07 |
| Date Received | 2006-09-13 |
| Date of Report | 2006-07-19 |
| Date of Event | 2006-07-18 |
| Date Mfgr Received | 2006-07-19 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2006-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DICK SMITH |
| Manufacturer Street | 910 BURSTEIN |
| Manufacturer City | ALBION MI 49224 |
| Manufacturer Country | US |
| Manufacturer Postal | 49224 |
| Manufacturer Phone | 5176298890 |
| Manufacturer G1 | OSSUR H/F |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICELOCK CLUTCH |
| Generic Name | ISS |
| Product Code | ISS |
| Date Received | 2006-09-13 |
| Returned To Mfg | 2006-08-24 |
| Model Number | L-214000 |
| Catalog Number | L-214000 |
| Lot Number | HF050211 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 749870 |
| Manufacturer | OSSUR H/F |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-09-13 |