BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 8889395 · Received August 13, 2019

    Report

    Report Number
    3005985723-2019-00590
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    August 9, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A MAKO IMPACTOR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCT WAS RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN 1 OTHER SIMILAR EVENT FOR THE REPORTED LOT. PR RELATES TO DAMAGE. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.  ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    WENT TO IMPACT THE TIBIAL TRIAL AND ITEM 160177 BROKE IN HALF. CASE TYPE: PKA.

    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

    WENT TO IMPACT THE TIBIAL TRIAL AND ITEM 160177 BROKE IN HALF. CASE TYPE: PKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682486 TIBIAL INLAY IMPACTOR HEAD STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 12100616

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization