BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 2926040 · Received January 23, 2013

    Report

    Report Number
    2530088-2013-00061
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    November 16, 2012
    Report Date
    December 28, 2012
    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

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NOT PREVIOUSLY REPORTED. ADDITIONAL CODES: MNH, MNI, KWQ, KWP. SCREW RECEIVED ASSEMBLED. THERE ARE SIGNS OF THREAD DAMAGE ON TWO OPPOSITE WINGS - ANODIZE REMOVAL AND DISCOLORATION PRESENT WITH LINES ON MINOR DIAMETER INDICATING POSSIBLE WRONG APPROACH ANGLE WITH LOCKING SCREW. THERE ARE NICKS AND SCRATCHES ON SD25 FACE ON THE SCREW AND OUTER SURFACE OF THE BODY. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. D3 FAILED DUE TO AS-RECEIVED NOTED DAMAGE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WE HAVE SENT THE COMPLAINED PEDICLE SCREW TO THE RESPONSIBLE PRODUCT MANAGER FOR INVESTIGATION; HERE THE RESULT: A DEFORMATION AT THE LOWER LEDGE OF THE ENTRANCE THREAD OF THE SCREW HEAD CAN BE OBSERVED. IN A FUNCTIONAL CONTROL, A LOCKING CAP 04.632.000 COULD BE INSERTED WITHOUT PROBLEMS. THE SCREW HEAD PERFORMED AS INTENDED. AS THE FAILURE WAS NOT REPRODUCIBLE, THE ROOT CAUSE FOR THE FAILURE COULD NOT BE IDENTIFIED. THE FAILURE COULD BE RELATED TO THE USED LOCKING CAP, TO THE PERSUADER USED OR TO THE HANDLING OF THE INSTRUMENT. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE OPERATION WAS PERFORMED FOR THE PURPOSE OF THE RE ASSESSMENT OF A LUMBAR DEGENERATIVE SPONDYLOLISTHESIS. DURING THE INSERTION OF THE SETSCREW INTO PEDICLE SCREW MATRIX BY USING A PERSUADER, THE SETSCREW WAS STOPPED AROUND THE FIRST THREAD. THE NEW SETSCREW PACK WAS OPENED AND THE DOCTOR TRIED TO INSERT; THE NEW SETSCREW COULD NOT BE INSERTED. SURGEON REMOVED THE PEDICLE SCREW, SELECTED ANOTHER SCREW AND COMPLETED THE PROCEDURE. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31803 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM PEDICSCREW MATRIX NKB SYNTHES BRANDYWINE 8025750

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR PEDICLE SCREW, LOCKING SCREW, LOCKING CAP