MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANT; MANDIBLE IMPLANT

Model Number	OP7544
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Discomfort (2330); Insufficient Information (4580)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
According to the initial report, the prosthesis broke inside the patient when the surgeon was fixinfg it.The surgeon was unable to replace it which created aesthetic imperfections.
Event or Problem Description
According to the initial report, the prosthesis broke inside the patient when the surgeon was fixinfg it.The surgeon was unable to replace it which created aesthetic imperfections.
Additional Manufacturer Narrative
According to the initial report, the prosthesis broke inside the patient when the surgeon was fixing it.The surgeon was unable to replace it which caused aesthetic imperfections.Requests for additional information were made, and essential information was received.The implant was placed intraorally, and an ample tissue pocket was made.The surgeon used a blade to modify the implant during the initial surgery ((b)(6) 2023).The implant was broken during the initial surgery and the surgeon decided to leave the implant in the patient.There was no additional fixation used, and the patient had no abnormalities to their anatomy.The implant was removed due to the patient being unsatisfied with the aesthetic results.A review of the manufacturing records was performed for the device, op7544, lot 003020922, and revealed no deviations from process or non-conformity of product that would have contributed to the event.During the quality inspection of the implant, all attributes were found to be acceptable.Following the investigation, a definitive root cause could not be confirmed as all records indicate sufficient manufacturing and quality inspection performance.There were no deviations associated with the production of op7544, lot 003020922.In conclusion, although a definitive root cause could not be established, the instructions for use state that the success of any implant is dependent upon careful handling and proper surgical technique.Matrix surgical usa is committed to delivering surgical implants that meet the highest standards of quality.We thoroughly investigate all reported incidents and strive to establish a root cause that can prevent future reoccurrence.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Common Device Name: MANDIBLE IMPLANT
• Manufacturer (Section D): MATRIX SURGICAL USA; 98 bledsoe rd.; newnan GA 30265
• Manufacturer (Section G): MATRIX SURGICAL USA; 98 bledsoe rd.; newnan GA 30265
• Manufacturer Contact: darren troutman ; 98 bledsoe rd.; newnan, GA 30265 ; 4048554592
• MDR Report Key: 19183395
• Report Number: 3009383407-2024-00001
• Device Sequence Number: 17699332
• Product Code: JAZ
• UDI-Device Identifier: 00855421005673
• UDI-Public: 00855421005673
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024
• 2 Devices were Involved in the Event: 1 2

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: OP7544
• Device Lot Number: 003020922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• 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: Other
• Patient Age: 31 YR
• Patient Sex: Male