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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Impaired Healing (2378)

Event Date 04/25/2022

Event Type  Injury  

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 Description

Complainant reports patients received mandibular angle implants bilaterally and subsequently experienced displacement, poor wound healing and pain the right side device was explanted approximately 11 months post-operatively.(note: this is the same patient associated with report # 2028924-2022-00004.This report represents the right side device.Report # 2028924-2022-00004 is the report for the left side device.).

• Brand Name: CONFORM MANDIBULAR ANGLE(TM)
• Type of Device: 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: 14497832
• MDR Text Key: 292691887
• Report Number: 2028924-2022-00005
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: M724CMA14R1
• UDI-Public: M724CMA14R1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CMA-14R
• Device Lot Number: 888735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male