BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP/THIGH/HINGE COVER

    MDR report key: 8509157 · Received April 12, 2019

    Report

    Report Number
    2921578-2019-00016
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    January 8, 2019
    Report Date
    August 27, 2019
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    KME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PROBLEM WAS INITIALLY REPORTED AS RELATED TO THE PROAXIS TABLE. INVESTIGATION FOUND IT MIGHT ALSO BE RELATED TO THE TWO SINGLE-USE PAD COVERS, SO TWO ADDITIONAL REPORTS ARE BEING FILED SHOWING THE POSSIBLE ASSOCIATION OF THE INJURY WITH THOSE TWO DEVICES. 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 INSTRUCTIONS WITH THE CUSTOMER. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR REVEALED THAT THIS INCIDENT IS THE SAME ONE REPORTED AS 2921578-2019-0010.

    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.

    Additional Manufacturer Narrative · 1

    THIS PROBLEM WAS INITIALLY REPORTED AS RELATED TO THE PROAXIS TABLE. INVESTIGATION FOUND IT MIGHT ALSO BE RELATED TO THE TWO SINGLE-USE PAD COVERS, SO TWO ADDITIONAL REPORTS ARE BEING FILED SHOWING THE POSSIBLE ASSOCIATION OF THE INJURY WITH THOSE TWO DEVICES. 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 INSTRUCTIONS WITH THE CUSTOMER.

    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
    302220 HIP/THIGH/HINGE COVER COVERS KME MIZUHO ORTHOPEDIC SYSTEMS, INC. 6977-772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other