MAUDE Adverse Event Report: IMPLANTECH ASSOCIATE, INC. CONFORM MANDIBULAR ANGLE(TM); CHIN IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
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.).

• Brand Name: CONFORM MANDIBULAR ANGLE(TM)
• Common Device Name: CHIN IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATE, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 9752917
• Report Number: 2028924-2020-00002
• Device Sequence Number: 10074540
• Product Code: FWP
• UDI-Device Identifier: M724CMA8L1
• UDI-Public: M724CMA8L1
• Combination Product (Y/N): N
• PMA/510(K) Number: K905268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 08/14/2024
• Device Model Number: N/A
• Device Catalogue Number: CMA-8L
• Device Lot Number: 884347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR