BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROAXIS SPINAL SURGERY TABLE (INT'L)

    MDR report key: 8358172 · Received February 21, 2019

    Report

    Report Number
    2921578-2019-00010
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    January 3, 2019
    Report Date
    August 28, 2019
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430106880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO DETERMINE 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 IS THE SAME INCIDENT AS THAT REPORTED IN 2921578-2018-00038, 2921578-2019-00015 AND 2921578-2019-00016.

    Additional Manufacturer Narrative · 0

    UNABLE TO DETERMINE 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 · 0

    PATIENT WAS POSITIONED PRONE FOR T4-PELVIS FUSION UTILISING 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 MINIMISE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES IN THE FOLLOWING AREAS - EYELIDS, CHIN, LEFT PRECORDIAL REGION, RIGHT ILIAC CREST (LEFT AND RIGHT HIPS). THE LEFT AND RIGHT HANDS/WRIST ALSO HAD SOME SWELLING AND BLISTERING AND THE RIGHT CALF SUSTAINED A GRADE 2 TEAR. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 14 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

    Description of Event or Problem · 0

    PATIENT WAS POSITIONED PRONE FOR T4-PELVIS FUSION UTILISING 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 MINIMISE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES IN THE FOLLOWING AREAS - EYELIDS, CHIN, LEFT PRECORDIAL REGION, RIGHT ILIAC CREST (LEFT AND RIGHT HIPS). THE LEFT AND RIGHT HANDS/WRIST ALSO HAD SOME SWELLING AND BLISTERING AND THE RIGHT CALF SUSTAINED A GRADE 2 TEAR. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 14 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    PATIENT WAS POSITIONED PRONE FOR T4-PELVIS FUSION UTILISING 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 MINIMISE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES IN THE FOLLOWING AREAS - EYELIDS, CHIN, LEFT PRECORDIAL REGION, RIGHT ILIAC CREST (LEFT AND RIGHT HIPS). THE LEFT AND RIGHT HANDS/WRIST ALSO HAD SOME SWELLING AND BLISTERING AND THE RIGHT CALF SUSTAINED A GRADE 2 TEAR. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 14 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153425 PROAXIS SPINAL SURGERY TABLE (INT'L) OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6988A--GT 00842430106880

    Patients

    Seq Age Sex Outcome Treatment
    1 Other