BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 2954930 · Received February 11, 2013

    Report

    Report Number
    2530088-2013-00138
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 15, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MEASURABLE DIMENSIONS OF THE COMPLAINED IMPLANT WAS CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-2. NO PRODUCT FAULT COULD BE DETECTED. WE CAN ONLY ASSUME THAT THE COLLET WAS BLOCKED IN ITS UPPER POSITION DURING THE INSERTION, THIS MIGHT HAVE BEEN THE CAUSE FOR THE LOOSENING OF THE HEAD. TO AVOID SUCH OCCURRENCE WE RECOMMEND THE USE OF THE ALIGNMENT TOOL FOR POLYAXIAL SCREW HEADS TO ADJUST THE HEADS. THIS DOES ALSO HELP TO AVOID A DISPLACEMENT OF THE COLLET.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING AN OPERATION THE HEAD OF THE SCREW WAS COMING OFF. THERE WASN'T ANY IMPACT ON THE PROCEDURE, THE OPERATION WAS FINISHED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58770 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM SCREW NKB SYNTHES BRANDYWINE 6991521

    Patients

    Seq Age Sex Outcome Treatment
    1