MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-25 for CONFORM MANDIBULAR ANGLE(TM) N/A CMA-8L manufactured by Implantech Associate, Inc..
[182510598]
Complainant reported that patient complained of swelling & a bad taste in his mouth 3 weeks after being implanted bilaterally. Subsequently, the patient had the left side device explanted due to a diagnosis of infection. No culture was taken, however pus was found during explant surgery. Complainant reports patient was seen 16 days after explant, and symptoms had resolved. (note: in (b)(6) 2019, patient did receive injections of "bellafill" in the same regions where mandibular implants were subsequently placed. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2020-00002 |
| MDR Report Key | 9752917 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-02-25 |
| 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 MANDIBULAR ANGLE(TM) |
| Generic Name | CHIN IMPLANT |
| Product Code | FWP |
| Date Received | 2020-02-25 |
| Model Number | N/A |
| Catalog Number | CMA-8L |
| Lot Number | 884347 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATE, INC. |
| Manufacturer Address | 6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-25 |