BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSP METATARSAL SHORTENING SYSTEM

    MDR report key: 10355802 · Received August 3, 2020

    Report

    Report Number
    3009540749-2020-00019
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    February 22, 2020
    Report Date
    August 3, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HRS
    PMA / PMN Number
    K140724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. DEVICE HISTORY RECORDS RELATED TO THE EVENT WERE REVIEWED. THERE WERE NO NON-CONFORMANCES DETECTED THROUGH THE DEVICE HISTORY RECORD REVIEW. IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A METATARSAL SHORTENING SYSTEM PROCEDURE WAS PERFORMED ON (B)(6) 2020 ON THE 2ND AND 3RD TOE. ON (B)(6) 2020 SURGEON REPORTED THE MSP PLATE CRACKED FROM THE SLIT TO THE DYNAMIC HOLE ON THE 3RD TOE (REPORTED UNDER 3009540749-2020-00017) AND ON (B)(6) 2020 IT WAS REPORTED THE SAME THING HAPPENED ON THE 2ND TOE. IN BOTH INSTANCES THE PATIENT HAS NO PAIN AND PRODUCT REMAINS IMPLANTED. SURGEON IS MONITORING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820244 MSP METATARSAL SHORTENING SYSTEM PLATE HRS NEXTREMITY SOLUTIONS 168415217B

    Patients

    Seq Age Sex Outcome Treatment
    1