MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for MINI MET HEAD MMCI-13 manufactured by Vilex, Inc..
[54437821]
On august 17, 2016, vilex received call that implant broke during surgery. Surgery was performed on patient's lesser toe. Account manager reported while the doctor was turning the implant the head of the implant snapped off the stem. The doctor was able to remove the stem portion of the implant from the patient and was able to implant another vilex mini met head without issue. Doctor reported that the patients bone was "like marble". Implants for lesser toes are very small and with the hardness of the bone, there is a possibility it could break at that point. Vilex was unable to evaluate the actual device as it was discard by the facility. The lot number is unknown, so no evaluation could be completed on an implant from the same lot. If more information could become available a follow up report will be completed.
Patient Sequence No: 1, Text Type: N, H10
[54437822]
Implant broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051526-2016-00007 |
| MDR Report Key | 5922312 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-11 |
| Date Mfgr Received | 2016-08-17 |
| Date Added to Maude | 2016-09-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SYLVIA SOUTHARD |
| Manufacturer Street | 111 MOFFITT STREET |
| Manufacturer City | MCMINNVILLE TN 37110 |
| Manufacturer Country | US |
| Manufacturer Postal | 37110 |
| Manufacturer Phone | 8005215002 |
| Manufacturer G1 | VILEX, INC. |
| Manufacturer Street | 111 MOFFITT STREET |
| Manufacturer City | MCMINNVILLE TN 37110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MINI MET HEAD |
| Generic Name | MINI MET HEAD |
| Product Code | KWD |
| Date Received | 2016-09-01 |
| Model Number | MMCI-13 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VILEX, INC. |
| Manufacturer Address | 111 MOFFITT STREET MCMINNVILLE TN 37110 US 37110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-01 |