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

Model Number	N/A
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	10/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary attached: method: the actual device was not returned, however production records were analyzed which including sterilization records, labeling, environmental monitoring, and historical data review.Results: no failure of the device itself was reported or found during investigation.Conclusions: the reported events are known inherent risks of device and associated surgical procedures.Labeling addresses the possibility of complications such as infection and extrusion.
Event or Problem Description
Complainant reported that patient complained of pain and swelling on the left side approximately 1 week after having mandibular angle implants placed bilaterally.Physician suspected possible infection and patient was treated with antibiotics (amoxicillin p.O.) and pain medications (toradol p.O.) over the next several weeks.Approximately 1 month post-operatively, the patient reported that he spat up the left side device while gargling.Complainant reports that device appears intact.No culture was taken.Patient is doing fine and has no symptoms of infection, and surgery to replace the left side device has been scheduled.(note: explant date listed is represents date device completely extruded out of the patient.).

• Brand Name: WIDENING MANDIBULAR ANGLE(TM)
• Common Device Name: MANDIBULAR IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 8271469
• Report Number: 2028924-2019-00001
• Device Sequence Number: 2055999
• Product Code: FWP
• UDI-Device Identifier: M724WMA5L1
• UDI-Public: M724WMA5L1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K905268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 02/19/2021
• Device Model Number: N/A
• Device Catalogue Number: WMA-5L
• Device Lot Number: 865024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR