BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM VA LOCKING BUTTRESS PIN WITH T8 STARDRIVE RECESS/18MM

    MDR report key: 2960278 · Received February 14, 2013

    Report

    Report Number
    1719045-2013-00301
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NOT PREVIOUSLY REPORTED. ADDITIONAL CODE: HRS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PATIENT IDENTIFIER: 608614988. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A PROCEDURE SURGEON COULD NOT REMOVE THE BUTTRESS PIN FROM THE VA LCP PLATE. SURGEON WANTED TO REPOSITION THE PIN 02.210.088 DURING IMPLANTATION. PIN HAD LOCKED TO THE PLATE SO SURGEON WAS UNABLE TO REPOSITION IT. PIN AND PLATE REMAIN IMPLANTED. SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS AND THE PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS 2 OF 2 REPORTS FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64375 1.8MM VA LOCKING BUTTRESS PIN WITH T8 STARDRIVE RECESS/18MM VA LOCKING BUTTRESS PIN HWC SYNTHES MONUMENT 7057490

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR