MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-19 for CONFORM (TM) EXTENDED ANATOMICAL CHIN N/A CEAC-M manufactured by Implantech Associates, Inc..
[105937311]
Actual device has not yet been returned for evaluation, however return is anticipated. As lot number of device was not provided, implantech was unable to review specific manufacturing records. Currently, implantech has no results or conclusions.
Patient Sequence No: 1, Text Type: N, H10
[105937312]
Complainant reported that patient complained of numbness and swelling approximately 4 weeks post surgery after having chin implant implanted. The physician found the end of the arm of the chin implant was kinked or bent at 90 degree angle on the patient's right side. The physician elected to explant and replace the device. Explant/replacement surgery occurred approximately 7 weeks post-operatively. The physician indicated that the end of the device had broken off. After replacement surgery, patient is reported to be doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00003 |
| MDR Report Key | 7443485 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-19 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2018-03-22 |
| Date Added to Maude | 2018-04-19 |
| 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 | MR. CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFORM (TM) EXTENDED ANATOMICAL CHIN |
| Generic Name | CHIN IMPLANT |
| Product Code | FWP |
| Date Received | 2018-04-19 |
| Returned To Mfg | 2018-04-27 |
| Model Number | N/A |
| Catalog Number | CEAC-M |
| Lot Number | NI |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-19 |