BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3030078 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-00845
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 5, 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

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED AND IS ENTERING THE COMPLAINT SYSTEM. THE INVESTIGATION IS ONGOING.

    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. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS PERFORMED AND STATES THE FOLLOWING: MAGNUM MANUFACTURED THE RETAINING SLEEVE ¿ FOR MATRIX. DUE TO AN UNKNOWN CAUSE, THE THREADED TIP BROKE. THE MATERIAL AND HARDNESS OF THE INNER SLEEVE WAS CONFIRMED TO BE WITHIN SPECIFICATION. THE THREADS, THREADED TIP DEPTH AND LOCATION WERE UNABLE TO BE VERIFIED DUE TO THE DAMAGE ON THE TIP. THE PARTS ALL PASSED INSPECTION AT THE TIME OF MANUFACTURING. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING POSITION. (B)(6).

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS PERFORMED AND STATES THE FOLLOWING: THE DEVICE WAS SENT TO THE RESPONSIBLE PRODUCT DEVELOPMENT CENTER FOR INVESTIGATION. THE INVESTIGATION HAS SHOWN THAT THE ARTICLES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. IT WAS DETERMINED THAT A PART OF THE PRIMELOCK THREAD WAS BROKEN OFF. IT WAS SUGGESTED THAT THE DAMAGES HAPPENED BECAUSE THE RETAINING SLEEVE WAS NOT TIGHTENED ENOUGH IN THE PRIMELOCK THREAD. IT IS ALSO REASONABLY SUGGESTED THAT THE CONNECTION BETWEEN RETAINING SLEEVE AND PEDICLE SCREW WAS DISSOLVED UNINTENTIONALLY (BY HOLDING THE GREEN KNOB) DURING SCREWING. THIS IN COMBINATION WITH HIGH LATERAL FORCES ON THE SCREW CAN FINALLY LEAD TO AN OVERLOAD AND TO A BREAKAGE OF THE THREAD.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS PERFORMED AND STATES THE FOLLOWING: THE SCREWS SPHERICAL OUTER DIAMETER CANNOT BE MEASURED AFTER FINISHING, THE PEELED M6.5 X 0.75-6H THREAD CANNOT BE MEASURED BECAUSE OF DAMAGE, AND THE COLLETS INTERNAL DIAMETER CANNOT BE MEASURED IN ITS MANUFACTURED SPLIT CONDITION.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE TIP OF THE RETAINING SLEEVE BROKE OFF DURING SCREW INSERTION: DIFFICULT SOFT TISSUE SITUATION, THE CONNECTION BETWEEN THE SCREW AND THE HOLDING SLEEVE BECAME LOOSE AND THE TIP OF THE INSTRUMENT AS WELL AS THE PRIMELOCK BROKE OFF. THIS IS 4 OF 4 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 4 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134072 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES BRANDYWINE 7002342

    Patients

    Seq Age Sex Outcome Treatment
    1