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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Swelling (2091)

Event Date 10/27/2018

Event Type  Injury  

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 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)
• 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: 8271469
• MDR Text Key: 133936414
• Report Number: 2028924-2019-00001
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: M724WMA5L1
• UDI-Public: M724WMA5L1
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• 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: 47 YR