BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEST SUPPORT SECTION ASSY.

    MDR report key: 12159320 · Received July 13, 2021

    Report

    Report Number
    2921578-2021-00018
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    May 14, 2021
    Report Date
    September 10, 2021
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430104343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON INTERVIEW WITH CUSTOMER (AND WITHOUT HAVING DEVICE) IT WAS DETERMINED THE CRACK OCCURRED FROM IMPROPER REMOVAL OF CHEST PLATE. TRAINING HAS TAKEN PLACE FOR THE STAFF ON PROPER SETUP. IN ADDITION MIZUHO OSI HAS THE STEPS LOCATED IN THE USER MANUAL WHICH WAS ALSO POINTED OUT WHEN THERE IS HELP / QUESTIONS.

    Description of Event or Problem · 0

    ADULT FEMALE TO OPERATING ROOM FOR TREATMENT OF T12 BURST FRACTURE SUSTAINED STATUS POST A FALL OUT OF BED A WEEK EARLIER. PLANNED PROCEDURE WAS OPEN TREATMENT, REDUCTION, AND KYPHOPLASTY T12 WITH TLL-LL POSTEROLATERAL BONE FUSION AND PEDICLE SCREW INSTRUMENTATION. PATIENT IS MORBIDLY OBESE, WT: 290 LB, BMI: 50. PATIENT WAS POSITIONED PRONE FOR SURGERY ON TRIOS TABLE AT 1351. AT 1358 A LOUD CRACK WAS HEARD AND THE PATIENT WAS NOTED TO HAVE SETTLED INTO THE TABLE FRAME. THE CHEST SUPPORT ON THE TABLE HAD CRACKED AND COMPLETELY FALLEN OFF. THE PATIENT WAS RESTING ON THE TWO RAILS OF THE TABLE, SUPPORTED BY HER BODY AND SHOULDERS. THERE WAS NO OBVIOUS HYPEREXTENSION, MALALIGNMENT, OR INJURY NOTED. THE INCISION WAS QUICKLY CLOSED AND THE PATIENT WAS TURNED SUPINE ONTO A STRETCHER AT 1400. A REPLACEMENT CHEST SUPPORT WAS OBTAINED AND THE PATIENT WAS REPOSITIONED PRONE AT 1404. THE PATIENT WAS THEN RE-PREPPED AND RE-DRAPED AND SURGERY PROCEEDED AS PLANNED. NO OBVIOUS INJURIES WERE NOTED UPON RETURNING THE PATIENT TO THE SUPINE POSITION POST-OP. NO ADDITIONAL DIAGNOSTIC IMAGING WAS OBTAINED RELATED TO THIS INCIDENT. THE WEIGHT LIMIT OF THE TRIOS TABLE IS 600LBS.

    Description of Event or Problem · 1

    ADULT FEMALE TO OPERATING ROOM FOR TREATMENT OF T12 BURST FRACTURE SUSTAINED STATUS POST A FALL OUT OF BED A WEEK EARLIER. PLANNED PROCEDURE WAS OPEN TREATMENT, REDUCTION, AND KYPHOPLASTY T12 WITH TLL-LL POSTEROLATERAL BONE FUSION AND PEDICLE SCREW INSTRUMENTATION. PATIENT IS MORBIDLY OBESE, WT: (B)(6) LB, BMI: 50. PATIENT WAS POSITIONED PRONE FOR SURGERY ON TRIOS TABLE AT 1351. AT 1358 A LOUD CRACK WAS HEARD AND THE PATIENT WAS NOTED TO HAVE SETTLED INTO THE TABLE FRAME. THE CHEST SUPPORT ON THE TABLE HAD CRACKED AND COMPLETELY FALLEN OFF. THE PATIENT WAS RESTING ON THE TWO RAILS OF THE TABLE, SUPPORTED BY HER BODY AND SHOULDERS. THERE WAS NO OBVIOUS HYPEREXTENSION, MALALIGNMENT, OR INJURY NOTED. THE INCISION WAS QUICKLY CLOSED AND THE PATIENT WAS TURNED SUPINE ONTO A STRETCHER AT 1400. A REPLACEMENT CHEST SUPPORT WAS OBTAINED AND THE PATIENT WAS REPOSITIONED PRONE AT 1404. THE PATIENT WAS THEN RE-PREPPED AND RE-DRAPED AND SURGERY PROCEEDED AS PLANNED. NO OBVIOUS INJURIES WERE NOTED UPON RETURNING THE PATIENT TO THE SUPINE POSITION POST-OP. NO ADDITIONAL DIAGNOSTIC IMAGING WAS OBTAINED RELATED TO THIS INCIDENT. THE WEIGHT LIMIT OF THE TRIOS TABLE IS 600LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055927 CHEST SUPPORT SECTION ASSY. OPERATING TABLE TORSO POSITIONER JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5840-580 00842430104343

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR