MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. EXTENDED ANATOMICAL CHIN; CHIN IMPLANT

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect-clinical code: bacterial infection (staph aureus) health effect-impact code: surgical intervention (explantation of device) medical device problem code: patient device interaction problem (note: this code selected because patient had infection after having implant placed, but this may not be a device problem.) type of investigation: though device was not returned, implantech performed a review of production records and trend analysis.(no errors or omissions were identified which might account for the reported event.) investigation findings: no device problem found.Investigation conclusions: infection is a known inherent risk of this kind of surgical procedure, and the event is addressed in the product labeling.
Event or Problem Description
Complainant reported that patient had chin implant explanted after slightly more than 4 months due to infection.About 14 weeks post-op, the patient reported swelling.A cyst at the site was drained and cultured, and staph aureus was identified.Patient was treated with oral bactrim which briefly resolved symptoms, however the cyst came back (redness and swelling).It was cultured again and staph aureus was identified.Shortly after, device was explanted.Reporting physician's office now indicates symptoms appear to be resolved.

• Brand Name: EXTENDED ANATOMICAL CHIN
• 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: 20746993
• Report Number: 2028924-2024-00002
• Device Sequence Number: 8614146
• Product Code: FWP
• UDI-Device Identifier: M724EACS1
• UDI-Public: M724EACS1
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K902825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2024

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
• Device Model Number: N/A
• Device Catalogue Number: EAC-S
• Device Lot Number: 907575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2024
• 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: FACE AND NECK LIFT.LATERAL BROW LIFT.FAT GRAFTING.; FAT GRAFTING.; LATERAL BROW LIFT.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female