MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for DORNHOFFER ALTO TOTAL SHOE/WIN 626 manufactured by Grace Medical.
[91945341]
(b)(6) has two semi circles in the head of the implant that we call phalanges centering around the head of the implant; the phalange broke off on handling the implant for placement. This is the second implant of this exact same type where the phalange broke off, the first was not reported. (b)(6) alto total shoe/win lot 56720, exp date: 04/28/2022.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073239 |
| MDR Report Key | 7024432 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-10-26 |
| Date Added to Maude | 2017-11-13 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DORNHOFFER ALTO TOTAL SHOE/WIN |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR, REPLACEMENT |
| Product Code | ETB |
| Date Received | 2017-11-13 |
| Returned To Mfg | 2017-11-01 |
| Model Number | 626 |
| Catalog Number | 626 |
| Lot Number | 56720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MEDICAL |
| Manufacturer Address | MEMPHIS TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-13 |