BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ASSY

    MDR report key: 7920117 · Received September 28, 2018

    Report

    Report Number
    3005985723-2018-00559
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 6, 2018
    Report Date
    March 18, 2021
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486002923
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS RE-OPENED FOLLOWING RETURN OF THE DEVICE. THIS REPORT IS BEING SUBMITTED TO DOCUMENT THAT UPON FURTHER REVIEW OF THIS EVENT AND THE ASSOCIATED RISK DOCUMENTATION, IT IS NOTED THAT THIS EVENT IS NOT REPORTABLE. A REVIEW OF THE ASSOCIATED RISK DOCUMENT FOR TOTAL HIP ARTHROPLASTY MAKO SYSTEM FOR SYSTEM ELEMENTS FRACTURE DURING USE INDICATES THAT THE HIGHEST POTENTIAL SEVERITY OF HARM IS S2 WITH A POTENTIAL OCCURRENCE LEVEL O3. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DATA FOR THE PAST 4 YEARS INDICATED THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR DEATH AS A RESULT OF SIMILAR EVENTS WITH THIS DEVICE FAMILY. BASED UPON THIS REVIEW, IT IS UNLIKELY THAT A SERIOUS INJURY OR DEATH WOULD RESULT IF THIS EVENT WERE TO RECUR. THEREFORE, THIS EVENT IS NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. IT WAS REPORTED THAT ATTACHMENT SCREW PELVIC ARRAY MAKO THA BROKE DUE TO WEAR AND HIGH FORCES. THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED UNDER LOT 19470117 AND ACCEPTED INTO FINAL STOCK ON 04/07/2017. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112230, LOT NUMBER 19470117 SHOWS 01 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR:1855096. THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    ATTACHMENT SCREW PELVIC ARRAY MAKO THA BROKE DUE TO WEAR AND HIGH FORCES. OPENED NEW THA ARRAY KIT.

    Description of Event or Problem · 0

    ATTACHMENT SCREW PELVIC ARRAY MAKO THA BROKE DUE TO WEAR AND HIGH FORCES. OPENED NEW THA ARRAY KIT.

    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

    ATTACHMENT SCREW PELVIC ARRAY MAKO THA BROKE DUE TO WEAR AND HIGH FORCES. OPENED NEW THA ARRAY KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761744 PELVIC ARRAY ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 112230 LOT 19470117 00848486002923

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O