BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L70 SST

    MDR report key: 2891892 · Received December 31, 2012

    Report

    Report Number
    2520274-2012-04418
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 3, 2012
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON (B)(6) 2012, A PLATE WAS SECURED WITH THE INCORRECT SIZE SCREWS. THE PLATE REQUIRED SCREWS THAT ARE BETWEEN 75MM TO 90MM, BUT INSTEAD THE PLATE WAS SECURED WITH SCREWS THAT ARE 70MM. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKSCR Ø3.5 SELF-TAP L70 SST SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATES, SCREWS