MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. LATERAL MANDIBULAR ANGLE(TM); MANDIBULAR IMPLANT

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: the actual device was not evaluated, however implantech reviewed production records as well as performing trend analysis.Results: no device problem was found.There have been no other report complaints with either the manufacturing lot or associated sterile lot.Conclusions: displacement and extrusion are known inherent risks of implant procedures, and are addressed in the product labeling.
Event or Problem Description
This is the same patient associated with mdrs # 2028924-2022-00006 and 2028924-2022-00010.This event is associated with right side mandibular angle implant which was explanted approximately 14 months post-op.Though the device may have been removed prophylactically due to infection concerns on the device associated with mdr # 2028924-2022-00006, the patient/complainant indicated that the surgeons who removed the device had indicated that "everything was out of place and the right side was ready to tear the mucosa and come to the surface.".

• Brand Name: LATERAL MANDIBULAR ANGLE(TM)
• Common Device Name: MANDIBULAR 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: 14788930
• Report Number: 2028924-2022-00009
• Device Sequence Number: 12289160
• Product Code: FWP
• UDI-Device Identifier: M724TMA0410R1
• UDI-Public: M724TMA0410R1
• Combination Product (Y/N): N
• PMA/510(K) Number: K905268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

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: 04/24/2022
• Device Model Number: N/A
• Device Catalogue Number: TMA-4R/10
• Device Lot Number: 871099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• 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: TMA-4L/10; TSCI-M
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male