BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA 360 PATIENT POSITIONING SYSTEM

    MDR report key: 11845344 · Received May 18, 2021

    Report

    Report Number
    3004608878-2021-00358
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    April 23, 2021
    Report Date
    July 14, 2021
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT UNDERWENT AN ARNOLD CHIARI PROCEDURE AND WAS INITIALLY POSITIONED PRONE DURING THE PROCEDURE AND WAS NOT REPOSITIONED AT ANY TIME DURING SURGERY. THE DEVICE WAS USED WITH AN INTEGRA ADULT DISPOSABLE PINS. MAYFIELD ULTRA 360 POSITIONING SYSTEM (A2009) WAS REMOVED AND REPLACED WITH ANOTHER ONE TO COMPLETE THE PROCEDURE, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Additional Manufacturer Narrative · 0

    THE ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR): THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE REPORTED COMPLAINT WAS CONFIRMED FROM THE EVALUATION. THE UNIT RECEIVED WITH STD. ADAPTOR AND NOT THE TRI-STAR ADAPTOR. THE EVALUATION SHOWED THAT THE UPPER AND LOWER HANDLES ARE OUT OF ADJUSTMENT. BOTH SHOCK CUSHIONS ARE WORN. THE UNIT NEEDS REPAIR, AND REPLACEMENT OF WORN PARTS. GENERAL MAINTENANCE AND CLEANING REQUIRED. DEVICE EXCEEDS ITS EXPECTED LIFE OF 7 YEARS (MANUFACTURED IN 2008). NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE AND AFTER THE THE PATIENT'S HEAD WAS PINNED AND ENSURING THAT HEAD WAS SECURED, IT SEEMED AS IF THE MAYFIELD ULTRA 360 PATIENT POSITIONING SYSTEM (A2009) FAILED TO STAY LOCKED FOR THE NEXT FEW MINUTES AND SLIPPED ABOUT AN INCH. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739377 ULTRA 360 PATIENT POSITIONING SYSTEM BASE UNITS AND ADAPTERS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR