BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO DISPOSABLE SKULL PINS

    MDR report key: 6983831 · Received October 27, 2017

    Report

    Report Number
    3003923584-2017-00045
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 6, 2017
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONL INFORMATION ARE PART OF RECALL 3003923584-10-27-2017-001-R.

    Additional Manufacturer Narrative · 1

    PLEASE SEE MDR 3003923584-2017-00049.

    Description of Event or Problem · 1

    THIS IS FOLLOW-UP 01.

    Description of Event or Problem · 1

    FIRST CONTACT: QM DEPARTMENT WAS CONTACTED ON OCTOBER 6TH 2017 FROM DISTRIBUTOR. DISTRIBUTOR STATED THAT THEY RECEIVED INFORMATION FROM A HOSPITAL CUSTOMER THAT AFTER A NECK SURGERY, THE NURSE OF THIS HOSPITAL NOTICED THAT THE TIP OF THE SKULL PIN WAS BROKEN, AND REMAINED IN THE PATIENTS HEAD. THE HOSPITAL HAS TAKEN OUT THE BROKEN TIP FROM THE PATIENT. THE BROKEN PIN WAS PLACED AT THE 2 PIN SIDE OF THE QR3 SKULL CLAMP. NO INJURY TO THE PATIENT IS REPORTED. SECOND CONTACT: QM DEPARTMENT WAS INFORMED ON OCTOBER 25TH 2017 FROM DISTRIBUTOR ABOUT AN SECOND PIN BREAKAGE IN THE SAME FACILITY. NO PATIENT INJURY REPORTED. THIS EVENT WILL BE REPORTED WITHIN MDR 3003923584-2017-00049.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763934 DORO DISPOSABLE SKULL PINS DISPOSABLE SKULL PINS,ADULT (36PCS) HBL PRO MED INSTRUMENTS GMBH 3006-00 17041

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR