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

Model Number	N/A
Health Effect - Clinical Codes	Bacterial Infection (1735); Fluid Discharge (2686)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: actual device was not returned, so implantech performed analysis of production records, including sterilization records, as well as performing trend analysis.(there have been no other complaints of infection related complications associated with the applicable sterile lot.) results: no device problem was found.Conclusion: infection is a known, inherent risk associated with implant surgery, and is addressed in the labeling for the product.
Event or Problem Description
Complainant reported that patient initially presented with issues more than 3 weeks post-operatively after chin implant was placed intraorally, and subsequently was diagnosed with an infection.Patient was started on cipro (p.O.) and doxycycline (p.O.) and a culture was taken.The culture identified staphylococcus aureus, and patient was switched to clyndomycin (p.O.) when symptoms did not resolve quickly, the patient had the site drained and received new courses of clyndomycin.Infection did not resolve, and patient had the device explanted approximately 10.5 weeks post-operatively.

• Brand Name: CONFORM(TM) EXTENDED ANATOMICAL CHIN
• Common Device Name: CHIN IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 11886916
• Report Number: 2028924-2021-00002
• Device Sequence Number: 3685356
• Product Code: FWP
• UDI-Device Identifier: M724CEACM1
• UDI-Public: M724CEACM1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K902825
• 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): 05/26/2021

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: 06/05/2025
• Device Model Number: N/A
• Device Catalogue Number: CEAC-M
• Device Lot Number: 888232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/26/2021
• 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: 26 YR