MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. TERINO SQUARE CHIN-STYLE I; CHIN IMPLANT

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: the actual device was not evaluated, however implantech reviewed production records as well as performing trend analysis.Results: no device problem was found.There have been no other report complaints with either the manufacturing lot or associated sterile lot.Conclusions: displacement is a known inherent risk of implant procedures, and is addressed in the product labeling.
Event or Problem Description
This is the same patient associated with mdrs # 2028924-2022-00006 and 2028924-2022-00009.This event is associated with a chin implant which was explanted approximately 14 months post-op.Though the device may have been removed prophylactically due to infection concerns on the device associated with mdr # 2028924-2022-00006, the patient/complainant indicated that the surgeons who removed the device had indicated that "everything was out of place.".

• Brand Name: TERINO SQUARE CHIN-STYLE I
• Common Device Name: CHIN IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• Manufacturer (Section G): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• Manufacturer Contact: craig arthur ; 6025 nicolle street, suite b; ventura, CA 93003 ; 8053399415
• MDR Report Key: 14788883
• Report Number: 2028924-2022-00010
• Device Sequence Number: 20098321
• Product Code: FWP
• UDI-Device Identifier: M724TSCIM1
• UDI-Public: M724TSCIM1
• Combination Product (Y/N): N
• PMA/510(K) Number: K902824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

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: 11/08/2024
• Device Model Number: N/A
• Device Catalogue Number: TSCI-M
• Device Lot Number: 885616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TMA-4L/10; TMA-4R/10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male