BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAKO ONLAY TUBE INSERT 010370

    MDR report key: 12587255 · Received October 6, 2021

    Report

    Report Number
    3005985723-2021-00166
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 13, 2021
    Report Date
    October 6, 2021
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 5;180515;UNKNOWN, MCK TIBIAL BASEPLATE-RM/LL-SZ 5;180615; UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT THAT HAD A MAKO KNEE SURGERY IN 2019 IS PRESENTING PAIN. OP DATE: (B)(6). ITEM ¿ PALACOS R & G 40G WITH GENTAMICIN BONE CEMENT 0.5G GENTAMICIN. MAKO FEM. COMP. 180515. MAKO ONLAY TIB 180615. MAKO ONLAY TUBE INSERT 010370.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484683 UNKNOWN MAKO ONLAY TUBE INSERT 010370 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention