BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ADAPTOR ASSY

    MDR report key: 9373759 · Received November 25, 2019

    Report

    Report Number
    3005985723-2019-00841
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 6, 2019
    Report Date
    February 25, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486002930
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: PELVIC ARRAY AND PELVIC ARRAY CLAMP GOT CROSS THREADED AND NEED TO BE REPLACED. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION. THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION CAPA 2127499 HAS BEEN RAISED FOR THE SAME. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 31 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 10/31/2011. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112240, LOT NUMBER 19010811 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    PELVIC ARRAY AND PELVIC ARRAY CLAMP GOT CROSS THREADED AND NEED TO BE REPLACED. CASE TYPE: THA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PELVIC ARRAY AND PELVIC ARRAY CLAMP GOT CROSS THREADED AND NEED TO BE REPLACED. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162190 PELVIC ARRAY ADAPTOR ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 112240 19010811 00848486002930

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization