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

Model Number	OP8321
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Inflammation (1932)
Date of Event	05/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that due to the infection, the whole implant was explanted, but was not returned and no further information was made available.The complainant made no indication that the omnipore implant reliability or performance were contributing factors to the adverse event.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.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient or procedural details.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 were discarded and not available for evaluation.Retained sample from same lot was evaluated for packaging defects.No defects observed.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.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 feb.21, 2018 indicating that a physician reported patient developed a post-surgical infection after the implantation of an omnipore two-piece chin (op8321).Device was implanted on (b)(6) 2017.It was reported that 1 month after surgery the patient began to have an inflammatory reaction, secretion, edema and swelling.The physician drained the site and prescribed antibiotic.The patient had an improvement for 15 days, then came back presenting the same inflammatory condition.The physician performed a surgery removing and cleaning the implanted device, treating patient with antibiotic, and re-implanted the original device.After 2 weeks, patient returned with all the same reactions and on (b)(6) 2018 the implanted device was removed.Today the patient is well.

• Brand Name: OMNIPORE SURGICAL IMPLANT - TWO-PIECE CHIN - MEDIUM
• Common Device Name: MEDIUM TWO-PIECE CHIN
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all road; suite 120; atlanta GA 30349 1876
• MDR Report Key: 8318300
• Report Number: 3009383407-2018-00001
• Device Sequence Number: 1649910
• Product Code: KKY
• UDI-Device Identifier: 00855421005253
• UDI-Public: 00855421005253
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/01/2021
• Device Model Number: OP8321
• Device Catalogue Number: OP8321
• Device Lot Number: 030070616
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• 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: 20 YR