MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-20 for VILEX MINI MET HEAD MMCI-13 manufactured by Vilex, Inc..
[37234171]
On (b)(6) 2015 - vilex received a call from a facility that the doctor explanted a broken mmci-13. The doctor was unaware of the date the device was implanted, when or how the implant broke. Vilex requested that the implant be returned. On 01/06/2016, vilex received the broken implant. Vilex's quality control department evaluated the implant and could not find a product flaw which would cause the breakage. Without more detailed info, vilex is unable to determine the cause of the breakage. After a review of vilex's complaint log, no other complaints were found against this device size. If more info should become available, a f/u report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[37234172]
Mini met head implant broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051526-2016-00001 |
| MDR Report Key | 5396698 |
| Date Received | 2016-01-20 |
| Date of Report | 2016-01-20 |
| Date of Event | 2015-12-28 |
| Date Mfgr Received | 2015-12-28 |
| Device Manufacturer Date | 2009-06-12 |
| Date Added to Maude | 2016-01-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 111 MOFFITT STREET |
| Manufacturer City | MCMINNVILLE TN 37110 |
| Manufacturer Country | US |
| Manufacturer Postal | 37110 |
| Manufacturer Phone | 9314747550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VILEX MINI MET HEAD |
| Generic Name | MINI MET HEAD |
| Product Code | KWD |
| Date Received | 2016-01-20 |
| Returned To Mfg | 2016-01-06 |
| Model Number | MMCI-13 |
| Lot Number | 4023 |
| 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 | MCMINNVILLE TN 37110 US 37110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-20 |