BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP RADIOLUCENT

    MDR report key: 6953954 · Received October 17, 2017

    Report

    Report Number
    3003923584-2017-00044
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    September 18, 2017
    Report Date
    September 20, 2017
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435502181
    PMA / PMN Number
    K032331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SO FAR WE DO NOT KNOW IF A PATIENT GOT HURT WITH THIS DEVICE, THE INFORMATION IS STILL MISSING. BUT AS THE AWARENESS DATE WAS ON SEPTEMBER 16TH WE DECIDED TO REPORT THE INCIDENT ANYWAY, TO MAKE A FOLLOW-UP POSSIBLE IF THERE ARE FURTHER INFORMATION AVAILABLE. THE PIN PRESSURE HAD A MINOR DEVIATION ON 1 OF 4 MEASURING POINTS. CONSIDERING THE MINOR DEVIATION OF THE DEVICE WE ASSUME THAT THE DEVICE DID NOT CONTRIBUTE TO THE DESCRIPTION OF THE POSSIBLE EVENT.

    Description of Event or Problem · 1

    WE RECEIVED FURTHER INFORMATION ON 23RD OCTOBER 2017 FROM HOSPITAL. USER (HOSPIAL) STATED: THE INJURY WAS AN EVENT THAT OCCURRED PRIOR TO NOTICING THE ISSUE THAT THIS DORO HEAD-HOLDER WAS SENT TO YOUR COMPANY FOR EVALUATION AND REPAIR. THE PRESSURE ON THE TORQUE KNOB WAS SET AT 60 POUNDS AND THE HEAD-HOLDER SLIPPED WHEN THE SURGICAL RESIDENT AND THE SURGICAL TEAM WENT TO POSITION THE PATIENT. WE WERE INSTRUCTED BY PMI TO SET PRESSURES WHEN APPLYING THE DORO TO THE PATIENT TO 80 POUNDS WHEN USING THE AIRO AND THE TRUMPF TABLE. UNFORTUNATELY, THE SURGICAL RESIDENT WAS MISINFORMED ALONG THE WAY AND SET IT AT 60 POUNDS. THIS RESULTED IN 2 SCALP LACERATIONS. HE HAS BEEN INSTRUCTED BY THE SURGICAL ATTENDING, AND THE STEREOTACTIC INFORMATION SPECIALIST THAT WHEN USING THE DORO HEADHOLDER WITH THE AIRO AND AIRO BED ATTACHMENTS BY TRUMPF, THE PRESSURE SHOULD BE SET AT 80 POUNDS. DUE TO THE INCIDENT THERE WAS A DELAY IN THE PROCEDURE. THE SKIN LACERATIONS HAD TO BE IDENTIFIED AND CLOSED. CUSTOMER ASSUMED TO DETECT AN ISSUE AT THE TORQUE SCREW (PLEASE SEE AND SWITCHED TO BACKUP SKULL CLAMP AND NEW PINS. ALL TOLL, PATIENT HAD THE DORO PLACED THREE TIMES BEFORE USER COULD ACTUALLY SAFELY TO SURGERY.

    Description of Event or Problem · 1

    PMI WAS CONTACTED ON (B)(6) 2017 STATING THE TORQUE SCREW IS LOOSE AND NEEDS REPAIR. THE REPORTER SAID "WE ARE EXPERIENCING THE SAME ISSUE WHERE THE TORQUE SCREW IS LOOSE AND WE CAN'T GET ENOUGH PRESSURE TO SECURE THE HEAD IN POSITION". THE ITEM WAS RECEIVED ON 09/25/2017. THE RGA FORM STATED THERE WAS A RISK FOR PATIENT INJURY. PROCEDURE WAS SPINE FUSION IN PRONE POSITION, SURGERY WAS COMPLETED. DATE OF INCIDENT WAS (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734392 DORO® SKULL CLAMP RADIOLUCENT DORO® SKULL CLAMP RADIOLUCENT HBL PRO MED INSTRUMENTS GMBH 3034-00 04250435502181

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention