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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 10/03/2022

Event Type  Injury  

Event Description

Complaint reported that patient had a chin implant explanted approximately 5.5 months post-operatively due to an infection.A culture taken found that a minimal load of staphylococcus aureus was identified.

Manufacturer Narrative

Methods: the actual device was not evaluated, however implantech reviewed production records, as well as performing trend analysis.There have been no other reports of infection with either the manufacturing lot or associated sterile lot.Results: no device problem was found.Conclusion: infection is a known, inherent risk of implant procedures and is addressed in the product labeling.

• Brand Name: TERINO EXTENDED ANATOMICAL(TM) CHIN
• 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: 15676808
• MDR Text Key: 302468636
• Report Number: 2028924-2022-00011
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: M724TEACM1
• UDI-Public: M724TEACM1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902825
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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: TEAC-M
• Device Lot Number: 896496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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: 32 YR
• Patient Sex: Female