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

Model Number	N/A
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378)
Date of Event	04/25/2022
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 is only one other complaint associated with this product lot and associated sterile lot, and it involves the same reporting physician.Conclusions: the reported events are known, inherent risk of implant procedures and are addressed in the product labeling.
Event or Problem Description
Complainant reports patients received mandibular angle implants bilaterally and subsequently experienced displacement, poor wound healing and pain the left side device was explanted approximately 11 months post-operatively.(note: this is the same patient associated with report # 2028924-2022-00005.This report represents the left side device.Report # 2028924-2022-00005 is the report for the right side device.).

• Brand Name: CONFORM 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: 14497809
• Report Number: 2028924-2022-00004
• Device Sequence Number: 5645691
• Product Code: FWP
• UDI-Device Identifier: M724CMA14L1
• UDI-Public: M724CMA14L1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: 06/26/2025
• Device Model Number: N/A
• Device Catalogue Number: CMA-14L
• Device Lot Number: 888511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male