BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHELL IMPACTION PLATFORM

    MDR report key: 9378235 · Received November 26, 2019

    Report

    Report Number
    3005985723-2019-00848
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 1, 2019
    Report Date
    March 26, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486022082
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT IMPACTION PLATFORM BROKE WHILE IMPACTING. PRODUCT EVALUATION AND RESULTS: PR 2232387 COULD NOT BE COMPLETED AS THE 206270 SHELL IMPACTION PLATFORM WAS NOT PROVIDED. THREE COMMUNICATION ATTEMPTS WERE MADE AND APPROPRIATE INFORMATION WAS NOT RECEIVED. PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 103 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 03/31/2016 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N: 206270, LOT: 45030116 SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINTS ARE PR: 1938874, 1950484. 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

    IMPACTION PLATFORM BROKE WHILE IMPACTING. 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

    IMPACTION PLATFORM BROKE WHILE IMPACTING. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169362 SHELL IMPACTION PLATFORM STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 206270 45030116 00848486022082

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization