BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE RADIOLUCENT SKULL PINS

    MDR report key: 7552512 · Received May 30, 2018

    Report

    Report Number
    8043933-2018-00015
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 3, 2018
    Manufacturer
    BRAINLAB AG
    Product Code
    HBL
    UDI-DI
    04056481004767
    PMA / PMN Number
    K122225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A FAILURE OF HEAD FIXATION DURING A CRANIAL SURGERY HAS OCCURRED, WITH THE BRAINLAB DEVICE INVOLVED, ALTHOUGH: THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE CORRESPONDING MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE ACCORDING TO THE HOSPITAL, THE SURGERY WAS COMPLETED SUCCESSFULLY, NO FURTHER NEGATIVE CLINICAL EFFECT OCCURRED (BESIDES THE LACERATIONS DESCRIBED), AND NO FURTHER REMEDIAL ACTIONS ARE NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE (BESIDES THE STITCHES DESCRIBED). ACCORDING TO THE RESULTS OF BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE MAIN ROOT CAUSE FOR THE FACT THAT THE PATIENT'S HEAD SLIPPED OUT OF THE FIXATION IS AN INSUFFICIENT ENGAGEMENT OF THE PINS IN THE SKULL. FURTHER CONTRIBUTING FACTORS ARE: VARYING TABLE POSITIONS WITH UP TO 23 DEGREE TABLE INCLINATION. OBESE PATIENT CONDITION WITH LARGE AMOUNT OF TISSUE / FAT IN SUBCUTANEOUS LAYER OF SCALP. HEAD CLAMP SETUP WITH ONLY ONE PIN POSTERIOR AND TWO PINS ON FOREHEAD WITH PATIENT IN SUPINE POSITION (DUE TO LOCATION OF SURGERY SITE JUST BEHIND PATIENT'S LEFT EAR). THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE. CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE. BRAINLAB INTENDS TO: INFORM THIS HOSPITAL ABOUT THE INVESTIGATION RESULTS. CORRESPONDING TO THE ROOT CAUSE, BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

    Description of Event or Problem · 1

    A PATIENT WAS FIXATED IN THE PMI DORO RADIOLUCENT SKULL CLAMP USING BRAINLAB RADIOLUCENT PINS DURING A CRANIAL PROCEDURE (A TRANSMASTOID CRANIOTOMY FOR RESECTION OF AN ENDOLYMPHATIC SAC TUMOR). THE SURGEON EXPERIENCED DIFFICULTIES IN PLACING THE PINS, ESP. TO VERIFY THAT THE PIN TIPS WERE IN COMPLETE CONTACT WITH THE SKULL, DUE TO A SIGNIFICANT AMOUNT OF FAT IN THE SUBCUTANEOUS LAYER OF THE PATIENT'S SCALP. SEVERAL TABLE MANEUVERS WERE PERFORMED TO CONFIRM THAT THERE WAS NO MOVEMENT OF THE PATIENT HEAD, AND STABILITY OF THE FIXATION WAS DETERMINED SATISFACTORY FOR THE PROCEDURE. DURING THE CASE, AFTER APPROX. 7H, WHILE THE SURGICAL RESECTION CAVITY WAS BEING INSPECTED FOR ADDITIONAL TUMOR (SURGEON WAS INSIDE WITH FORCEPS, AND CRITICAL BRAIN STRUCTURES WERE EXPOSED), THE PATIENT HEAD JERKED IN A SINGLE, RAPID MOVEMENT. THE HEAD SLIPPED OUT OF THE TWO PINS ON THE FOREHEAD. THIS CAUSED A LACERATION OF 1-2 CM ON THE RIGHT HAND SIDE WHICH NEEDED STITCHES, THE PUNCTURE ON THE LEFT HAND SIDE WAS LARGER THAN USUAL BUT DID NOT REQUIRE STITCHES. THE PATIENT HEAD COULD BE STABILIZED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ACCORDING TO THE HOSPITAL, THE SURGERY WAS COMPLETED SUCCESSFULLY, NO FURTHER NEGATIVE CLINICAL EFFECT OCCURRED (BESIDES THE LACERATIONS DESCRIBED), AND NO FURTHER REMEDIAL ACTIONS ARE NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE (BESIDES THE STITCHES DESCRIBED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394417 DISPOSABLE RADIOLUCENT SKULL PINS NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) HBL BRAINLAB AG 18910-01A 8168717001 04056481004767

    Patients

    Seq Age Sex Outcome Treatment
    1 Other