MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-03-06 for AMIS MOBILE LEG POSITIONER manufactured by Medacta International, Sa.
[4236055]
Reference importer report # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11763888]
From the document review of the lot involved (1111566 - sn (b)(4)) no anomalies were found. The failure mode is unlikely to cause pt harm, even if it can lead to additional steps to fix the problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005180920-2014-00024 |
| MDR Report Key | 3716276 |
| Report Source | 00 |
| Date Received | 2014-03-06 |
| Date Mfgr Received | 2014-02-04 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2014-04-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ADAM GROSS |
| Manufacturer Street | 1556 W CARROL AVE. |
| Manufacturer City | CHICAGO IL 60607 |
| Manufacturer Country | US |
| Manufacturer Postal | 60607 |
| Manufacturer Phone | 3128782381 |
| Manufacturer G1 | MEDACTA INTERNATIONAL, SA |
| Manufacturer Street | STRADA REGINA 6874 |
| Manufacturer City | CASTEL SAN PIETRO |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMIS MOBILE LEG POSITIONER |
| Generic Name | LEG POSITIONER FOR HIP IMPLANTATION |
| Product Code | FWX |
| Date Received | 2014-03-06 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL, SA |
| Manufacturer Address | CASTEL SAN PIETRO SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-06 |