MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-17 for VILEX MINI METHEAD MMCI-13 manufactured by Vilex, Inc..
[40796117]
Device was implanted on september 8, 2015. On (b)(6) 2016, surgery was performed to remove the implant as it had broken. The head of the implant was removed. Surgeon left the stem portion in the patient's toe. The breakage of the device was due to the patient slipping on the floor and enduring significant blunt force trauma by slamming toes into the wall. This force caused the device to break at the point where the head meets the stem of the device. If more information should become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[40796118]
Mini methead implant broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051526-2016-00002 |
| MDR Report Key | 5509004 |
| Date Received | 2016-03-17 |
| Date of Report | 2016-03-02 |
| Date of Event | 2016-02-02 |
| Date Mfgr Received | 2011-02-07 |
| Device Manufacturer Date | 2011-02-07 |
| Date Added to Maude | 2016-03-17 |
| 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 | 9314747550 |
| 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 | VILEX MINI METHEAD |
| Generic Name | MINI METHEAD |
| Product Code | KWD |
| Date Received | 2016-03-17 |
| Returned To Mfg | 2016-02-08 |
| Model Number | MMCI-13 |
| Lot Number | 4494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-03-17 |