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

Model Number	N/A
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Hemorrhage/Blood Loss/Bleeding (1888); Failure of Implant (1924); Fluid Discharge (2686); Physical Asymmetry (4573); Swelling/ Edema (4577)
Date of Event	06/04/2021
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 report complaints with either the manufacturing lot or associated sterile lot.Conclusions: poor wound healing, extrusion, infection, etc.Are all known, inherent risks of implant procedures, and are addressed in the product labeling.
Event or Problem Description
The patient/complainant reported receiving several facial implants, then subsequently experienced the stitches at site of left side mandibular implant opening with an outflow of fulid and blood (approximately 5 days post-op).Seven (7) days post-op, the doctor sewed up the incision site.Four (4) weeks post-op, the stitches had reopened, and were again sewed up under local anesthesia.Five (5) weeks post-op, the doctor sewed up the incision for the third time because they had again reopened.Almost 7 weeks postop, patient reported to physician that the stitches had opened more than ever and the implant was visible.Approximately eight (8) weeks post-op, patient had a second operation under total anesthesia, where the doctor "removed the implant, reconstructed the area, sterilized the implant clinically himself and placed it again, placing 1 screw intraorally".Three (3) months after the second surgery, the post-operative swwelling had not subsided.The patient had lost faith in the original doctor, and saw another physician who suggested a possible infection.Patient saw another doctor who diagnosed asymmetry in the face with severe swelling on the left side.The doctor prescribed an antibiotic (dalicin) to treat the infection.While taking the antibiotic, a slight reduction in swelling was observed, but after the course of antibiotics, the swelling returned and the physician recommended he visit another doctor.The device was explanted due to left side infection approximately 14 months post-op.A culture was taken and staphylococcus epidermidis was identified.

• Brand Name: LATERAL 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: 14714156
• Report Number: 2028924-2022-00006
• Device Sequence Number: 5562348
• Product Code: FWP
• UDI-Device Identifier: M724TMA0410L1
• UDI-Public: M724TMA0410L1
• Combination Product (Y/N): N
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2022

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: 06/22/2022
• Device Model Number: N/A
• Device Catalogue Number: TMA-4L/10
• Device Lot Number: 871988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TMA-4R/10; TSCI-M
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male