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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Date 08/30/2021

Event Type  Injury  

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 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
• Type of Device: 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: 12598982
• MDR Text Key: 275879733
• Report Number: 2028924-2021-00005
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: M724TSCIIXL1
• UDI-Public: M724TSCIIXL1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TSCII-XL
• Device Lot Number: 893750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR