MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-12-17 for PYLON TUBE 36" 238024 F119 manufactured by Fillauer, Inc..
[176825]
Pt was walking down a concrete sidewalk and upon taking a normal step the pylon tube in her above knee prosthesis broke. The pt fell suffering some bruises and soreness. The pylon tube was used in the assembly of an "ak" prosthesis with a seattle select knee and a voyager foot. The tube broke near or within the housing of the knee joint. The mfr received notification on 10/08/1999 and requested the product be returned for inspection. The product was returned on 11/04/1999 and then inspected by engineering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022826-1999-00001 |
| MDR Report Key | 255666 |
| Report Source | 05 |
| Date Received | 1999-12-17 |
| Date of Report | 1999-12-09 |
| Date of Event | 1999-10-06 |
| Date Mfgr Received | 1999-11-04 |
| Date Added to Maude | 1999-12-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG DAVIS |
| Manufacturer Street | P.O. BOX 5189 2210 AMNICOLA HWY |
| 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 | PYLON TUBE 36" |
| Generic Name | PYLON TUBE |
| Product Code | ISS |
| Date Received | 1999-12-17 |
| Returned To Mfg | 1999-11-04 |
| Model Number | 238024 |
| Catalog Number | F119 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 247566 |
| Manufacturer | FILLAUER, INC. |
| Manufacturer Address | 2710 AMNICOLA HWY. P.O. BOX 5189 CHATTANOOGA TN 37406 US |
| Baseline Brand Name | PYLON TUBE, 36" |
| Baseline Generic Name | PYLON TUBE |
| Baseline Model No | 238024 |
| Baseline Catalog No | 238024 |
| Baseline Device Family | EXTERNAL LIMB COMPONENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-12-17 |