BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN

    MDR report key: 6750159 · Received July 28, 2017

    Report

    Report Number
    6750159
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    June 27, 2017
    Report Date
    July 5, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 1

    THE SURGEON WAS DRILLING THE PIN AND THE TIP BROKE OFF. APPROXIMATELY 1-2MM OF THE TIP BROKE OFF IN THE LEFT TIBIA. TIP WAS UNABLE TO BE RETRIEVED. MANUFACTURER RESPONSE FOR MAKO PIN TIP, STRYKER / MAKO SURGICAL CORP (PER SITE REPORTER). REP AWARE.

    Description of Event or Problem · 1

    THE SURGEON WAS DRILLING THE PIN AND THE TIP BROKE OFF. APPROXIMATELY 1-2MM OF THE TIP BROKE OFF IN THE LEFT TIBIA. TIP WAS UNABLE TO BE RETRIEVED. MANUFACTURER RESPONSE FOR MAKO PIN TIP, STRYKER / MAKO SURGICAL CORP (PER SITE REPORTER) = REP AWARE.

    Description of Event or Problem · 1

    THE SURGEON WAS DRILLING THE PIN AND THE TIP BROKE OFF. APPROXIMATELY 1-2MM OF THE TIP BROKE OFF IN THE LEFT TIBIA. TIP WAS UNABLE TO BE RETRIEVED. MANUFACTURER RESPONSE FOR MAKO PIN TIP, STRYKER / MAKO SURGICAL CORP (PER SITE REPORTER). REP AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530402 BONE PIN ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 143080 W4520

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR