BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXNEURO STERILE KIT STD 4

    MDR report key: 3527333 · Received December 19, 2013

    Report

    Report Number
    8030965-2013-05582
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    November 7, 2013
    Report Date
    November 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS FOR REPORTED KIT: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. FOR BROKEN SCREW: K042365 FOR THE REPORTED KIT: INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. FOR THE BROKEN SCREW: REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE NEUROSURGEON TOOK THE SCREW (#04.503.104.20, LOT 7370187) WITH THE SCREWDRIVER AND WHEN HE WAS APPLYING THE SCREW, THE TIP OF THE SCREW BROKE OFF. THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING A NEW KIT. THE EVENT HAPPENED DURING SURGERY (CLOSING OF CRANIAL OPERCULUM) BUT BEFORE USED ON A PATIENT. CONDITION OF PATIENT IMMEDIATELY AFTER EVENT: STABLE. NO HARM FOR THE PATIENT, THEY CHANGED SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667715 MATRIXNEURO STERILE KIT STD 4 JEY SYNTHES GMBH 8525815

    Patients

    Seq Age Sex Outcome Treatment
    1