MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-10-15 for FILLAUER MODULAR SHUTTLE LOCK 125461 manufactured by Fillauer, Llc.
[17017453]
The pt is a below knee amputee and was walking in their home when their prosthetic limb came loose. The prosthetist indicated that this limb was new and had been in use for only 8 days. The pt believed the lock released. They were able to stop and step back into the socket and continue walking. Later that afternoon their were in the bank and their limb came loose again. The prosthetic limb fell off and they landed on their residuum. They visited their prosthetist that day. Their prosthetist suggested they go to the clinic to be examined. They chipped the end of their tibia and will not be walking for 3-4 weeks. The pt also told their prosthetist that they had other occasions when they put the socket on the lock would click but the plunger located on the end of the liner would pull right back out of the lock. They would then reposition the liner and have no problem with the lock. The pt thought the clicking that they heard may have been the plunger trying to enter the lock at an angle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022826-2004-00001 |
| MDR Report Key | 549479 |
| Report Source | 05 |
| Date Received | 2004-10-15 |
| Date of Report | 2004-10-14 |
| Date of Event | 2004-09-15 |
| Date Mfgr Received | 2004-09-15 |
| Date Added to Maude | 2004-10-20 |
| 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 | SHERI HASSLER |
| Manufacturer Street | 2710 AMNICOLA HIGHWAY |
| Manufacturer City | CHATTANOOGA TN 37406 |
| Manufacturer Country | US |
| Manufacturer Postal | 37406 |
| Manufacturer Phone | 4236240946 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILLAUER MODULAR SHUTTLE LOCK |
| Generic Name | PROSTHETIC SUSPENSION LOCK |
| Product Code | IQO |
| Date Received | 2004-10-15 |
| Model Number | 125461 |
| Catalog Number | 125461 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 538971 |
| Manufacturer | FILLAUER, LLC |
| Manufacturer Address | * CHATTANOOGA TN * US |
| Baseline Brand Name | FILLAUER MODULAR SHUTTLE LOCK |
| Baseline Generic Name | PROSTHETIC SUSPENSION LOCK |
| Baseline Model No | 125461 |
| Baseline Catalog No | 125461 |
| Baseline Device Family | PROSTHESIS ALIGNMENT DEVICE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-10-15 |