MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-04-26 for ASI ASI-MD manufactured by Nexa Orthopedics, Inc..
[609056]
X-ray revealed angled subtalar implant (asi) migrated from original implanted position. Surgeon elected to remove original implant and replace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030833-2007-00007 |
| MDR Report Key | 843777 |
| Report Source | 05,07 |
| Date Received | 2007-04-26 |
| Date of Report | 2007-04-26 |
| Date of Event | 2007-03-28 |
| Date Mfgr Received | 2007-04-02 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2007-05-10 |
| 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 | 11035 ROSELLE STREET |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASI |
| Generic Name | ANGLED SUBTALAR IMPLANT |
| Product Code | MJW |
| Date Received | 2007-04-26 |
| Returned To Mfg | 2007-04-02 |
| Model Number | ASI-MD |
| Catalog Number | ASI-MD |
| Lot Number | K07826 |
| Device Expiration Date | 2009-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 832469 |
| Manufacturer | NEXA ORTHOPEDICS, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2007-04-26 |