MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. FLOWERS MANDIBULAR GLOVE; CHIN IMPLANT

Model Number	N/A
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	01/20/2022
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 reports of infection or other complaints associated with either the manufacturing lot or associated sterile lot.Conclusions: infection is a known, inherent rist of implant procedure and is addressed in the product labelling.
Event or Problem Description
Complainant reported that patient had a chin implant explanted 3 weeks post-operatively due to infection.Patient had pus leaking from incision but otherwise remained asymptomatic.No culture was taken.Patient has no significant medical history reported, nor any use of concomitant therapies reported.
Event or Problem Description
Complainant reported that patient had a chin implant explanted 3 weeks post-operatively due to infection.Patient had pus leaking from incision but otherwise remained asymptomatic.No culture was taken.Patient has no significant medical history reported, nor any use of concomitant therapies reported.

• Brand Name: FLOWERS MANDIBULAR GLOVE
• Common Device Name: CHIN 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: 13481489
• Report Number: 2028924-2022-00001
• Device Sequence Number: 4493172
• Product Code: FWP
• UDI-Device Identifier: M724FMGVM1
• UDI-Public: M724FMGVM1
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/08/2022

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 Model Number: N/A
• Device Catalogue Number: FMG-VM
• Device Lot Number: 895950
• 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: 01/20/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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: 24 YR
• Patient Sex: Male