BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOSYNC¿ CB DBM PUTTY, 10CC

    MDR report key: 19357818 · Received May 21, 2024

    Report

    Report Number
    1220246-2024-03559
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    June 29, 2021
    Report Date
    May 21, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MQV
    UDI-DI
    10889981153694
    PMA / PMN Number
    K070751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. AS NO FURTHER INVESTIGATION WAS ABLE TO BE PERFORMED NO CHANGE IN HARM WAS IDENTIFIED. THIS COMPLAINT WILL BE INCLUDED IN TRENDING PER (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS 3 WEEKS OUT FROM ACL TUNNEL BONE GRAFTING WITH DOWELS PROCEDURE WHICH OCCURRED ON (B)(6) 2021. THAT WAS THE FIRST STAGE OF A REVISION FROM AN ACL PROCEDURE FROM YEARS AGO. DURING THE FIRST FOLLOW UP A WEEK POST OP ON (B)(6) 2021 THE PATIENT HAD MILD PAIN AND MODERATE SWELLING. ON (B)(6) THE PATIENT WENT TO THE EMERGENCY DEPARTMENT REPORTING THE SWELLING AND PAIN HAS INCREASED. ON (B)(6) 2021 HE CAME IN TO SEE THE DOCTOR AND THE EXAM REPORTED ACTIVE DRAINAGE OVER THE INCISION AND WAS DIAGNOSED WITH AN INFECTION. IT WAS DETERMINED ALL OF THE IMPLANTED ITEMS WILL NEED TO BE REMOVED INCLUDING THE ALLOSYNC PUTTY AND TWO DOWELS. ADDITIONAL INFORMATION: THE DOWELS (NOT AN ARTHREX ITEM) WERE REAMED OUT ALONG WITH THE PUTTY. THE ONLY ARTHREX PRODUCT REMOVED DURING THIS PROCEDURE WAS THE ABS-2014-10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220223 ALLOSYNC¿ CB DBM PUTTY, 10CC CALCIUM SULFATE PREFORM PELLET MQV ARTHREX, INC. ALLOSYNC¿ CB DBM PUTTY, 10CC 172787 10889981153694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O