MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. MITTELMAN(R) PRE JOWL CHIN (TM), EXTRA LARGE; CHIN IMPLANT

Model Number	N/A
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed sterilization records, manufacturing records (assembly and packaging), sterilization process records, and evaluated the labeling.Results: no failure was detected.Conclusion: the possibility of infection is a known, inherent risk associated with implant surgery.
Event or Problem Description
Complainant reported that patient had a chin implant explanted approximately 17 months post-operatively due to infection.The reporter indicated the infection appeared to occur in a hollow/void area at the end of the pocket on the left side.The culture on the patient came back positive for pseudomonas aeruginosa.Replacement surgery is tentatively planned after a suitable interval.

• Brand Name: MITTELMAN(R) PRE JOWL CHIN (TM), EXTRA LARGE
• Common Device Name: CHIN IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle st., suite b; ventura CA 93003
• MDR Report Key: 7538818
• Report Number: 2028924-2018-00004
• Device Sequence Number: 16764652
• Product Code: FWP
• UDI-Device Identifier: M724MPJCXL1
• UDI-Public: M724MPJCXL1
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K902826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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: Physician
• Device Expiration Date: 07/01/2017
• Device Model Number: N/A
• Device Catalogue Number: MPJC-XL
• Device Lot Number: 845757
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/23/2018
• 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: 54 YR