BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 8127972 · Received December 4, 2018

    Report

    Report Number
    3003923584-2018-00058
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 5, 2018
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS FOLLOW-UP 1: THE DEVICE WAS RECEIVED ON 03RD DECEMBER 2018. CONDUCTED VISUAL AND FUNCTIONAL TESTING/INSPECTION. RESULT: TORQUE SCREW PIN PRESSURE DEVIATION (SLIGHTLY TOO LOW). SOME DINGS WERE NOTED ON THE SURFACE OF THE DEVICE. CONCERNING THE REPORTED EVENT: AS THE DEVICE WAS OUT OF SPECIFICATION, IT GENERALLY CANNOT BE EXCLUDED THAT THE DEVICE HAS CONTRIBUTED TO THE EVENT. FROM OUR EXPERIENCE WE SUSPECT, THAT MAYBE THE PINNING TECHNIQUE HAS BEEN NOT OPTIMAL AS DESCRIBED IN THE INSTRUCTION MANUAL: "ADJUST THE SKULL CLAMP TO THE WIDTH OF THE PATIENT'S HEAD IN THE MANNER THAT THE TWO SKULL PINS IN THE ROCKER ARM ARE EQUIDISTANT FROM THE CENTERLINE OF THE HEAD AND THE SINGLE SKULL PIN AT THE EXTENSION ASSEMBLY IS IN LINE WITH THIS CENTERLINE."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IN THIS FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AS THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER STATED: "SWIVEL ARM SLIPPED WHILE POSITIONING PATIENT. WAS THERE A RISK FOR A PERSON/PATIENT RESULTING BY THE USE OF THE MEDICAL DEVICE? YES. PLEASE DESCRIBE RISK (AND POSSIBLE INJURIES): 5 CM LACERATION LEFT SCALP. PROCEDURE BEING PERFORMED: POSTERIOR CERVICAL FUSION. PATIENT POSITIONING: PRONE. WAS THE SURGERY COMPLETED? YES. DATE OF INCIDENT: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968636 DORO® SKULL CLAMP DORO® SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 3003-009

    Patients

    Seq Age Sex Outcome Treatment
    1