MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-24 for MICROSHOX GT PYLON SPS CATALOG manufactured by Design Co.
[616701]
Prosthetic shock pylon for amputees failure in field. Breakage due to thin aluminum wall section. Sixty-six pieces in field to be returned (recalled) asap. Product microshox gt-140, external product gt-190, gt-250, gt-350. (do not have all the details on failed product).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042774 |
| MDR Report Key | 844460 |
| Date Received | 2007-04-24 |
| Date of Report | 2007-04-24 |
| Date Added to Maude | 2007-05-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSHOX |
| Generic Name | GT-140, GT-190, GT-250, GT-350 |
| Product Code | ISS |
| Date Received | 2007-04-24 |
| Model Number | GT PYLON |
| Catalog Number | SPS CATALOG |
| Lot Number | 9/06 / 2/07 |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 831647 |
| Manufacturer | DESIGN CO |
| Manufacturer Address | 2055 E RIO SALADO PKWY #102 TEMPE AZ 85281 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-24 |