MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-07-03 for BIOPRO HORIZON SUBTALAR IMPLANT 17222 manufactured by Biopro, Inc..
[2874168]
Pt had surgery to implant subtalar. Two days later, implant was removed because, it was not seated properly. Surgeon replaced it with a competitor's implant.
Patient Sequence No: 1, Text Type: D, B5
[10094962]
Possibility that soft tissue or other foreign body found its way between the driver and the implant causing a problem. Possible that a kink or bend in the guide wire happened during surgery which may have caused the seating of implant to be off.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1833506-2012-00002 |
| MDR Report Key | 2651994 |
| Report Source | 08 |
| Date Received | 2012-07-03 |
| Date of Report | 2012-07-02 |
| Date of Event | 2012-04-27 |
| Date Mfgr Received | 2012-06-21 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2012-08-01 |
| 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 Street | 2929 LAPEER RD. |
| Manufacturer City | PORT HURON MI 48060 |
| Manufacturer Country | US |
| Manufacturer Postal | 48060 |
| Manufacturer Phone | 8109827777 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPRO HORIZON SUBTALAR IMPLANT |
| Generic Name | SUBTALAR |
| Product Code | NDL |
| Date Received | 2012-07-03 |
| Returned To Mfg | 2012-06-11 |
| Model Number | 17222 |
| Lot Number | 110270 |
| Device Expiration Date | 2016-07-01 |
| 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 | 2012-07-03 |