MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for VILEX HEMI IMPLANT CHI-2CH manufactured by Vilex, Inc..
[47258738]
On (b)(6) 2016, vilex received call from an account manager that during surgery the wire ceased on a 1st mpj hemi implant. On (b)(6) 2016, vilex received the implant. On (b)(6) 2016, vilex's quality department inspected the implant and found no issues. Qc department used a test wire and it passed freely thru the implant. Vilex suspects that the doctor bent the wire thus causing the implant to cease. If a wire has the slightest bend, the implant will not move. The facility had disposed of the wire. Without the actual wire that was used in surgery, vilex is unable to confirm complaint. If further information becomes available, a supplement report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[47258739]
Wire ceased in cannulated hemi implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051526-2016-00006 |
| MDR Report Key | 5686469 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-05-27 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2016-05-11 |
| Device Manufacturer Date | 2012-05-17 |
| Date Added to Maude | 2016-05-27 |
| 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 | VILEX HEMI IMPLANT |
| Generic Name | HEMI |
| Product Code | KWD |
| Date Received | 2016-05-27 |
| Returned To Mfg | 2016-05-19 |
| Model Number | CHI-2CH |
| Lot Number | 5269 |
| 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 | 2016-05-27 |