BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROAXIS

    MDR report key: 8260785 · Received January 18, 2019

    Report

    Report Number
    2921578-2018-00038
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    January 8, 2019
    Report Date
    August 28, 2019
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE UNABLE TO DETERMINE IF THE CHEST PAD REMAINED PROPERLY POSITIONED AFTER PATIENT TRANSFER, OR IF THE PATIENT HAD COMORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE PROBLEM. ADVISED THE DISTRIBUTOR TO DISCUSS THE OWNER'S MANUAL POSITIONING INSTRUCTION WITH THE CUSTOMER. WILL FILE TWO ADDITIONAL REPORTS TO SHOW THE POSSIBLE ASSOCIATION OF THE INJURY WITH THE CHEST PAD COVER AND HIP/THIGH PAD COVER. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR REVEALED THAT THIS INCIDENT IS THE SAME ONE REPORTED AS 2921578-2019-0010.

    Additional Manufacturer Narrative · 0

    WE ARE UNABLE TO DETERMINE IF THE CHEST PAD REMAINED PROPERLY POSITIONED AFTER PATIENT TRANSFER, OR IF THE PATIENT HAD COMORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE PROBLEM. ADVISED THE DISTRIBUTOR TO DISCUSS THE OWNER'S MANUAL POSITIONING INSTRUCTION WITH THE CUSTOMER. WILL FILE TWO ADDITIONAL REPORTS TO SHOW THE POSSIBLE ASSOCIATION OF THE INJURY WITH THE CHEST PAD COVER AND HIP/THIGH PAD COVER.

    Description of Event or Problem · 0

    PATIENT WAS POSITIONED PRONE FOR POSTERIOR APPROACH SURGERY UTILIZING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMIZE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES UNDER AREAS OF CONTACT AROUND STERNUM AND ASIS. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 13 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

    Description of Event or Problem · 0

    PATIENT WAS POSITIONED PRONE FOR POSTERIOR APPROACH SURGERY UTILIZING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMIZE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES UNDER AREAS OF CONTACT AROUND STERNUM AND ASIS. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 13 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    PATIENT WAS POSITIONED PRONE FOR POSTERIOR APPROACH SURGERY UTILIZING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMIZE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES UNDER AREAS OF CONTACT AROUND STERNUM AND ASIS. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 13 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54331 PROAXIS OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6988I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other