BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 7108916 · Received December 12, 2017

    Report

    Report Number
    3005985723-2017-00620
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 16, 2017
    Report Date
    March 1, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A MAKO IMPACTOR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE NO MEDICAL RECORDS WERE MADE AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND INSUFFICIENT INFORMATION WAS PROVIDED. IF THE DEVICE AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    TIBIA BASEPLATE POLY IMPACTOR TIP - PN 160177 BROKE OFF DURING IMPACTION. PLASTIC TIP BROKE. PKA CASE.

    Description of Event or Problem · 1

    TIBIA BASEPLATE POLY IMPACTOR TIP - PN 160177 BROKE OFF DURING IMPACTION. PLASTIC TIP BROKE. PKA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887894 TIBIAL INLAY IMPACTOR HEAD PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other