MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-07-23 for BIOPRO SUBTALAR IMPLANT 17222 manufactured by Biopro, Inc..
[1149975]
Patient had ejected the implant and it was re-inserted. It was then ejected again after the surgery. Implant was removed.
Patient Sequence No: 1, Text Type: D, B5
[8481313]
The length, diameter, and distance between threads were all within design specifications. Nothing was found wrong dimensionally or materially with the device. The implant was done as a lone procedure. No adjunctive procedures were done such as an achilles lengthening or a gastric resection which may have prevented the implant from dislodging.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1833506-2009-00001 |
| MDR Report Key | 1467804 |
| Report Source | 08 |
| Date Received | 2009-07-23 |
| Date of Report | 2009-07-22 |
| Date of Event | 2009-06-25 |
| Date Mfgr Received | 2009-07-13 |
| Device Manufacturer Date | 2007-02-26 |
| Date Added to Maude | 2010-02-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICK PRINGLE |
| Manufacturer Street | 17 SEVENTEENTH ST. |
| Manufacturer City | PORT HURON MI 48060 |
| Manufacturer Country | US |
| Manufacturer Postal | 48060 |
| Manufacturer Phone | 8109827777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPRO SUBTALAR IMPLANT |
| Generic Name | BONE FIXATION FASTENER |
| Product Code | NDL |
| Date Received | 2009-07-23 |
| Returned To Mfg | 2009-07-13 |
| Model Number | 17222 |
| Lot Number | 105737 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOPRO, INC. |
| Manufacturer Address | PORT HURON MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-23 |