MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. MITTELMAN PRE JOWL; CHIN IMPLANT (PRE JOWL)

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Airway Obstruction (1699); Ecchymosis (1818); Pain (1994); Swelling/ Edema (4577)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

Method: the actual device has not been returned to implantech, so implantech has performed analysis of production records (including sterilization records) as well as performing trend analysis.(there have been no other adverse event reports associated with this manufacturing lot or this sterilization lot.) results: no device problem was found.Conclusion: though the exact nature of the complaint with implantech's device remains vague, the events alleged appear to constitute known, inherent risks associated with implant surgery, and are addressed in the product labeling.

Event Description

Note: this is the same patient and same events reported in mfr report # 2028924-2021-00004.Legal complaint alleges that patient experienced a variety of symptoms after receiving implantech chin implant.The complaint cites a number of concommitant therapies and products performed/placed at the same time.These will be listed in this report.The legal complaint does not specify which events are specifically attributed to the subject implantech device.The symptoms alleged include edema, ecchymosis, pain, stiffness and swelling of lips, and problems with the nasal airway, etc.The device was alleged to have been explanted approximately 30 months post-operatively.

• Brand Name: MITTELMAN PRE JOWL
• Type of Device: CHIN IMPLANT (PRE JOWL)
• 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: 12275360
• MDR Text Key: 265128627
• Report Number: 2028924-2021-00003
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: +M724MPJS1
• UDI-Public: +M724MPJS1
• Combination Product (y/n): N
• PMA/PMN Number: K902827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2023
• Device Model Number: N/A
• Device Catalogue Number: MPJ-S
• Device Lot Number: 879679
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2018
• 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: 57 YR