BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARMORLINK 7.5MM

    MDR report key: 9745025 · Received February 24, 2020

    Report

    Report Number
    3006460162-2019-00068
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    October 25, 2019
    Report Date
    February 24, 2020
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    MBI
    PMA / PMN Number
    K130217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. REPORTED EVENT WAS NOT CONFIRMED. INVESTIGATION OF THE DHR DID NOT REVEAL ANY PROCESS DEVIATIONS OR INDICATIONS OF MANUFACTURING VARIATIONS THAT WOULD CONTRIBUTE TO THE OBSERVED FAILURE MODE. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS THERE WERE NO TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. CONCOMITANT DEVICE: ITEM NUMBER: (B)(4), ARMORLINK 7.5MM, LOT NUMBER: F132729. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2019-00067.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING AN ACL CORRECTION, THE PATIENT UNDERWENT A REVISION DUE TO MIGRATION OF THE SCREW. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210123 ARMORLINK 7.5MM FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ORTHOPEDIATRICS, INC N/A F132729

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention