BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L3

    MDR report key: 3193260 · Received June 27, 2013

    Report

    Report Number
    1719045-2013-01700
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 28, 2012
    Report Date
    April 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZL
    PMA / PMN Number
    K031807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION OF THE COMPLAINED SCREW SHOWS THAT THE TIP IS IN GOOD CONDITION. NO DEFORMATION COULD BE DETECTED. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENT THE EXACT REASON CAUSING THE REPORTED PROBLEM. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DURING A CASE FOR A TUMOR OF THE SKULL, IT WAS REPORTED THAT THE DOCTOR INSERTED THIS SCREW INTO SKULL ON, BUT THIS SCREW COULD NOT BE INSERTED INTO SKULL FROM THE FIRST TIME. THE DOCTOR FOUND THAT THE TIP OF THE SCREW WAS DULL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292574 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L3 DZL SYNTHES MONUMENT 6883123

    Patients

    Seq Age Sex Outcome Treatment
    1