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

Model Number	N/A
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: actual device was not returned, so implantech reviewed production records, as well as performing trend analysis.(there have been no other reports associated with this lot, or on the tscii-xl catalog number.Review found event(s) are not occurring more frequently or severely than anticipated.) results: no device problem was found.Conclusion: both displacement and poor wound healing are known, inherent risks with facial implant surgery, and are addressed in the labeling for the product.
Event or Problem Description
Complainant reported that patient who had intraoral placement of a chin implant, subsequently had device explanted 8 weeks post-operatively due to displacement and poor wound healing.

• Brand Name: TERINO SQUARE CHIN-STYLE II
• Common Device Name: CHIN IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 12598982
• Report Number: 2028924-2021-00005
• Device Sequence Number: 1453337
• Product Code: FWP
• UDI-Device Identifier: M724TSCIIXL1
• UDI-Public: M724TSCIIXL1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K902824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 06/16/2026
• Device Model Number: N/A
• Device Catalogue Number: TSCII-XL
• Device Lot Number: 893750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/08/2021
• 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: 35 YR