MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. CONFORM(TM) EXTENDED ANATOMICAL CHIN; CHIN IMPLANT

Model Number	N/A
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: the actual device was not returned as it was not explanted.Implantech performed an analysis of production records., as well as performing trend analysis.(no increased risk of revision surgery for poor wound healing has been identified.) results: no device problem was found.Conclusion: poor wound healing and revision/explant surgery are known, inherent risks associated with implant surgery, and are addressed in the labelling for the product.
Event or Problem Description
Complainant reported that patient returned to office 1 year post-op with an indentation in the middle of the chin directly under the incision line.Approximately 14 months post-op, complainant performed revision procedure on the patient in which the skin and granulation tissue overerlying the implant were excised.Pathology came back as acute and chronic inflammation.The implant was not removed, and procedure went well.(note: as physician has not offered an opinion on whether this procedure constituted surgical intervention needed to preclude permanent impairment of a body function or permanent damage to a body structure, or whether the device caused or contributed to the event, implantech has elected to report this event.).

• Brand Name: CONFORM(TM) EXTENDED ANATOMICAL CHIN
• Common Device Name: CHIN IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 10541035
• Report Number: 2028924-2020-00003
• Device Sequence Number: 571415
• Product Code: FWP
• UDI-Device Identifier: M724CEACL1
• UDI-Public: M724CEACL1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K902825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: Health Professional
• Device Expiration Date: 09/05/2023
• Device Model Number: N/A
• Device Catalogue Number: CEAC-L
• Device Lot Number: 879583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/16/2020
• 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: 71 YR