BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT ONLAY TRIAL-SIZE 3-8MM

    MDR report key: 5996810 · Received October 4, 2016

    Report

    Report Number
    3005985723-2016-00312
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 7, 2016
    Report Date
    December 29, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE DEVICE WAS NOT RETURNED. AN EVENT REGARDING WEAR INVOLVING AN MAKO TRIAL WAS REPORTED. CONCLUSIONS: THE WORN DEVICE WAS POINTED OUT BY SCRUB TECH. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT AND NO PATIENT INVOLVEMENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    SCRUB TECH POINTED OUT DURING PROCEDURE THAT INSERT HAS BECOME CHIPPED AND WORN OUT.

    Description of Event or Problem · 1

    SCRUB TECH POINTED OUT DURING PROCEDURE THAT INSERT HAS BECOME CHIPPED AND WORN OUT. UPDATE: THE INSERT WAS DESCRIBED AS CHIPPED AND WORN OUT BY THE SCRUB TECH PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649617 TIBIAL INSERT ONLAY TRIAL-SIZE 3-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other