MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANT - TWO-PIECE CHIN - LARGE; HDPE LARGE TWO-PIECE CHIN

Model Number	OP8322
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Edema (1820); Inflammation (1932); Patient Problem/Medical Problem (2688)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient complications have been reported.A review of the manufacturing documentation and sterilization documentation for the device in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.There is the possibility that clinical factors may have contributed to this event.At this time the cause of the infection is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.If additional information is received, it will be provided in a supplemental report.Device and packaging was discarded and not available for evaluation.Retained sample from same lot was evaluated for packaging defects.Corrected data: on 02/07/2019 - follow-up to correct manufacturer number on initial submission dated 03/22/2018.Operator of device - remove value of physician.Occupation - removed value of other: distributor.Event problem and evaluation codes - conclusion and method code removed; device and packaging were discarded and not available for evaluation.
Event or Problem Description
Email notification was received from our distributor (b)(4) on nov.30, 2018 indicating that a patient developed a post-surgical infection post the implant of an omnipore two-piece chin (op8322).The following information was received: the surgeon reported that they followed the protocol but even so could not mold the product which was extremely hard even warmed.After implantation, the prothesis got a space between it and the bone.After surgery, in the space between the prothesis and the bone, the patient began to have an inflammatory reaction, edema and pain.So then, the surgeon removed the implant and discarded it.Date of surgery: (b)(6) 2018.Patient´s name: (b)(6).Surgeon´s name: (b)(6).Product code: op8322.Lot: 9003070616.

• Brand Name: OMNIPORE SURGICAL IMPLANT - TWO-PIECE CHIN - LARGE
• Common Device Name: HDPE LARGE TWO-PIECE CHIN
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all road; suite 120; atlanta GA 30349 1876
• MDR Report Key: 8318307
• Report Number: 3009383407-2018-00002
• Device Sequence Number: 11178391
• Product Code: KKY
• UDI-Device Identifier: 00855421005499
• UDI-Public: 00855421005499
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2018
• Report Date (Section F): 11/30/2018

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: No Information
• Device Expiration Date: 06/01/2021
• Device Model Number: OP8322
• Device Catalogue Number: OP8322
• Device Lot Number: 003070616
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 27 MO
• Date Report to Manufacturer: 11/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 02/07/2019
• 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: 35 YR
• Patient Weight: 60