BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY BONE SCREW

    MDR report key: 5438213 · Received February 16, 2016

    Report

    Report Number
    2648920-2016-00041
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 19, 2016
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS REPORTED IN ERROR ON FOLLOW-UP MDR #0002648920-2016-00041-1 ON (B)(6)2016. THE SCREW RETURNED MEETS PRINT SPECIFICATION WHERE MEASURED AND HAS THREAD AND HEAD DAMAGE. THE SHELL WAS NOT RETURNED BECAUSE IT REMAINS IMPLANTED, THEREFORE, NO PHYSICAL EVALUATION COULD BE CONDUCTED. THE DEVICE HISTORY RECORDS (DHRS) WERE REVIEWED AND INDICATE THE DEVICES WERE MANUFACTURED TO SPECIFICATIONS, WITH NO ANOMALIES OR DEVIATIONS THAT WOULD HAVE AFFECTED THE SURGICAL OUTCOME OR CONTRIBUTED TO THE REPORTED EVENT. THESE DEVICES ARE USED FOR TREATMENT. COMPLAINT HISTORY SEARCHES FOUND THERE ARE NO ADDITIONAL COMPLAINTS FOR THE PRODUCT PART/LOT COMBINATIONS INVOLVED. DUE TO THE SHELL REMAINING IMPLANTED AND UNABLE TO EVALUATE, A ROOT CAUSE FOR THE REPORTED CONDITION COULD NOT BE DETERMINED WITH CERTAINTY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION ON THIS FORM IS NOW BEING REPORTED UNDER MANUFACTURING REPORT #0002648920-2016-03278. THE ORIGINAL SUBMISSION WAS REPORTED UNDER AN MFR NUMBER THAT WAS FEI-BASED AND NOT CFN-BASED. RESUBMITTING UNDER 2648920-2016-00041-3 INSTEAD OF 0002648920-2016-00041-2.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS UNABLE TO PLACE THE SCREW AS IT WAS TO BIG FOR THE HOLES AND COULD POTENTIALLY ALTERNATE THE METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95720 TRILOGY BONE SCREW LPH LPH ZIMMER, TURPEAUX INDUSTRIAL PARK 63092023

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR