BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAR EXTENSION

    MDR report key: 8431851 · Received March 19, 2019

    Report

    Report Number
    3005985723-2019-00250
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 28, 2019
    Report Date
    May 28, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED ISSUE: IT WAS REPORTED THAT THE BASE BAR EXTENSION WAS DAMAGED. PRODUCT HISTORY REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED AND 49 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 01/19/2017. A REVIEW OF QT17-06-0060 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 210070, LOT 601571 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. . INSPECTION: INSPECTION SHOWED NO DAMAGE TO THE PART. CONCLUSION: THE FAILURE MODE WAS NOT CONFIRMED. THE HAZARD/HARM COMBINATION FROM THIS COMPLAINT HAS BEEN PREVIOUSLY IDENTIFIED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAS BEEN NO NC OR CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    THE BAR EXTENSION ASSEMBLY HAS EXPOSED CARBON FIBERS. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Additional Manufacturer Narrative · 1

    AS PART OF 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

    THE BAR EXTENSION ASSEMBLY HAS EXPOSED CARBON FIBERS. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224295 BAR EXTENSION STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 601571 00848486031862

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization