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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

Methods: 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 reports of infection with either the manufacturing lot or associated sterile lot.Conclusion: infection is a known, inherent risk of implant procedures and is addressed in the product labeling.

Event Description

Complainant reported that patient had right side mandibular angle implant explanted 5 days post-op due to infection.(this is the same patient and same complainant reported in 2028924-2022-00008 which addresses 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: 14714153
• MDR Text Key: 294239445
• Report Number: 2028924-2022-00007
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: M724CMA12R1
• UDI-Public: M724CMA12R1
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• 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-12R
• Device Lot Number: 896296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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: 65 YR
• Patient Sex: Male