BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVARIDGE PLUG

    MDR report key: 18116139 · Received November 10, 2023

    Report

    Report Number
    2249852-2023-00023
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    June 1, 2023
    Report Date
    January 31, 2024
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPM
    UDI-DI
    00813954024400
    PMA / PMN Number
    K083742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL QUALITY CONTROL TESTING OF RESERVE PRODUCT AND PRODUCT FROM THE SAME LOT RETURNED BY THE DISTRIBUTOR WERE TESTING FOR STERILITY. THE PRODUCT WAS PROVEN TO BE STERILE. THE PARENT MDR IS MDR 2249852-2023-00020 (AND MDR 2249852-2023-00020 SUPPLEMENT 1) FOR SUSPECT DEVICE 1 OF 5. THIS MDR (2249852-2023-00023 AND 2249852-2023-00023 SUPPLEMENT 1) IS FOR SUSPECT DEVICE 3 OF 5. PLEASE REFER TO MDR NUMBERS 2249852-2023-00020 (AND 2249852-2023-00020 SUPPLEMENT 1), 2249852-2023-00022 (AND 2249852-2023-00022 SUPPLEMENT 1), 2249852-2023-00024 (AND 2249852-2023-00024 SUPPLEMENT 1) AND 2249852-2023-00025 (AND SUPPLEMENT 2249852-2023-00025 SUPPLEMENT 1) FOR THE OTHER REPORTED SUSPECT DEVICES. NO INITIAL REPORTER INFORMATION WAS PROVIDED. COMPLAINT WAS REPORTED TO MANUFACTURER BY DISTRIBUTOR. REPORTER INFORMATION WAS REQUESTED BUT NOT PROVIDED. ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED, INCLUDING: WHAT DEVICE WAS UTILIZED ON WHAT PATIENT, THE EXACT NUMBER OF PATIENTS AFFECTED, IF THERE WAS ANY SURGICAL DELAY, INFORMATION RELATED TO THE REPORTED EVENT, CURRENT PATIENT STATUS, AND CLARIFICATION ON PRODUCT INFORMATION PER PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER MULTIPLE FOLLOW-UPS. THERE ARE TWO PRODUCT CODES ASSOCIATED WITH THIS DEVICE: LYC AND NPM. SECTION D2 LISTS CODE NPM. FOR PRODUCT CODE LYC: PRODUCT CODE NAME: BONE GRAFTING MATERIAL, SYNTHETIC, DEVICE CLASS: CLASS II, CLASSIFICATION PANEL: 76-DENTAL, C.F.R. SECTION: 872.3930-BONE GRAFTING MATERIAL.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. ADDITIONAL QUALITY CONTROL RESULTS ARE PENDING. THE PARENT MDR IS MDR 2249852-2023-00020 FOR SUSPECT DEVICE 1 OF 5. THIS MDR IS FOR SUSPECT DEVICE 3 OF 5. PLEASE REFER TO MDR NUMBERS 2249852-2023-00020, 2249852-2023-00022, 2249852-2023-00024 AND 2249852-2023-00025 FOR THE OTHER REPORTED SUSPECT DEVICES. NO INITIAL REPORTER INFORMATION WAS PROVIDED. COMPLAINT WAS REPORTED TO MANUFACTURER BY DISTRIBUTOR. REPORTER INFORMATION WAS REQUESTED BUT NOT PROVIDED. ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED, INCLUDING: WHAT DEVICE WAS UTILIZED ON WHAT PATIENT, THE EXACT NUMBER OF PATIENTS AFFECTED, IF THERE WAS ANY SURGICAL DELAY, INFORMATION RELATED TO THE REPORTED EVENT, CURRENT PATIENT STATUS, AND CLARIFICATION ON PRODUCT INFORMATION PER PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER MULTIPLE FOLLOW-UPS. THERE ARE TWO PRODUCT CODES ASSOCIATED WITH THIS DEVICE: LYC AND NPM. SECTION D2 LISTS CODE NPM. FOR PRODUCT CODE LYC: PRODUCT CODE NAME: BONE GRAFTING MATERIAL, SYNTHETIC. DEVICE CLASS: CLASS II. CLASSIFICATION PANEL: 76-DENTAL. C.F.R. SECTION: 872.3930-BONE GRAFTING MATERIAL.

    Description of Event or Problem · 0

    LIMITED INFORMATION WAS PROVIDED. IT WAS REPORTED THAT "SEVERAL PATIENTS" NEEDED TO HAVE THE PRESERVARIDGE PLUGS REMOVED AND REDRAFTED. ALL PATIENTS EXPERIENCED PAIN AND SWELLING AT THE GRAFT SITE. MULTIPLE ITEM NUMBERS AND MULTIPLE LOT NUMBERS FOR THE EVENT WERE PROVIDED, HOWEVER IT WAS NOT SPECIFIED WHAT SPECIFIC DEVICE WAS UTILIZED ON EACH PATIENT. ONLY ONE EVENT DATE FOR THIS ISSUE. ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED, INCLUDING: THE EXACT NUMBER OF PATIENTS AFFECTED, IF THERE WAS ANY SURGICAL DELAY, INFORMATION RELATED TO THE REPORTED EVENT, CURRENT PATIENT STATUS, AND CLARIFICATION ON PRODUCT INFORMATION PER PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER MULTIPLE FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161552 PRESERVARIDGE PLUG SYNOSS COLLAGEN SYNTHETHIC MINERAL - COLLAGEN BONE GRAFT MATRIX NPM COLLAGEN MATRIX, INC. PRPREG SMCPN220901 00813954024400

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention