BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ADAPTOR ASSY

    MDR report key: 8816992 · Received July 23, 2019

    Report

    Report Number
    3005985723-2019-00530
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486002930
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT "ARRAY ADAPTER BROKE OFF WHILE TIGHTENING." THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112240, LOT 19080913 SHOWS 00 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES 49 DEVICE(S) WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 12DEC2013 AND 01 DEVICE(S) WERE REJECTED. REVIEW OF QT13-12-0018 INDICATES THE FOLLOWING: 01 DEVICE(S) WERE QUARANTINED DUE TO SCREW MISPLACEMENT; THE PART WAS RTV. PRODUCT HISTORY REVIEW SHOWS THE NONCONFORMANCE(S) DID NOT CONTRIBUTE TO THE EVENT ALLEGED IN THIS COMPLAINT. -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112240, LOT 19080913 SHOWS 00 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE PRODUCT WAS NOT RECEIVED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO CONFIRMED FAILURE MODE. H3 OTHER TEXT : PRODUCT WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    ARRAY ADAPTER BROKE OFF WHILE TIGHTENING 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

    ARRAY ADAPTER BROKE OFF WHILE TIGHTENING . CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611900 PELVIC ARRAY ADAPTOR ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19080913 00848486002930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization