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	11/04/2020
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 complication 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 presented with issues 8 days after chin implant was placed intraorally, and was subsequently diagnosed with an infection.Patient was treated with cipro (p.O.) and doxyclyclin (p.O.), however when results of a culture identified streptococcus viridans, the area was drained and patient was switched to clyndomycin (p.O.) the patient's symptoms did not improve, and the patient had the site drained and new courses of clyndomycin (p.O.) prescribed.The infection is now considered to be resolved.

• 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: 11886733
• Report Number: 2028924-2021-00001
• Device Sequence Number: 19754217
• 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: 2020
• 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: 09/25/2025
• Device Model Number: N/A
• Device Catalogue Number: CEAC-M
• Device Lot Number: 889776
• 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: 21 YR