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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Swelling (2091); Numbness (2415)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Actual device has not yet been returned for evaluation, however return is anticipated.As lot number of device was not provided, implantech was unable to review specific manufacturing records.Currently, implantech has no results or conclusions.
Event or Problem Description
Complainant reported that patient complained of numbness and swelling approximately 4 weeks post surgery after having chin implant implanted.The physician found the end of the arm of the chin implant was kinked or bent at 90 degree angle on the patient's right side.The physician elected to explant and replace the device.Explant/replacement surgery occurred approximately 7 weeks post-operatively.The physician indicated that the end of the device had broken off.After replacement surgery, patient is reported to be doing well.
Additional Manufacturer Narrative
Evaluation summary: method: actual device has now been evaluated, and labeling for device evaluated.Results: evaluation suggests that "user interface" contributed to the event.Conclusion: damage to implantable medical devices during surgery is a known, inherent risk of the procedure.Labeling warns that "utmost care should be taken to avoid damage to the implant during handling or in surgery.Avoid contact with sharp objects such as surgical instruments.".

• 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: 7443485
• Report Number: 2028924-2018-00003
• Device Sequence Number: 2052640
• Product Code: FWP
• UDI-Device Identifier: M724CEACM1
• UDI-Public: M724CEACM1
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K902825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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 Model Number: N/A
• Device Catalogue Number: CEAC-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/08/2018
• 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: 32 YR