BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIC-SCR-MATR Ø7 PERF L55 TAN

    MDR report key: 3183153 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03355
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 20, 2012
    Report Date
    May 8, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE ADDITIONAL EVALUATION REVEALED THAT THE PRIME-LOCK THREAD A DAMAGED THREAD SIDE AT THE ENEMA. THE OTHER RETAINING SLEEVE IS FINE. BOTH BONE SCREWS ARE BOTH BROKEN ON THREE FOURTHS OF THE UPPER EDGE (PRIMELOCK THREAD). A POSSIBLE CAUSE FOR THE CHIP FORMATION WHEN INSERTING THE SCREW MAY BE THE DAMAGED ENEMA OF THE PRIMELOCK THREAD OF THE RETAINING SLEEVE. THE DAMAGE MAY HAVE LEAD TO AN IMPROPER JOINT BETWEEN RETAINING SLEEVE AND SCREW WAS NOT PROPER WHAT LEAD TO AN OVERLOAD ON THE EDGE OF THE BONE SCREW AND THE CHIP WAS SOLVED. THE CAUSE FOR THE DAMAGED THREAD SIDE CANNOT BE DETERMINED. IT IS PROBABLY CAUSED BY NORMAL WEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A METAL CHIP WAS LOOSENED FROM THE SCREW HEAD WHEN INSERTING THE BONE SCREW. ONE OF THE RETAINING SLEEVES SHOWS AT THE PRIME-LOCK THREAD A DAMAGED THREAD SIDE AT THE ENEMA. THE OTHER RETAINING SLEEVE IS FINE. BOTH BONE SCREWS ARE BROKEN THREE FOURTHS OF THE UPPER EDGE (PRIME-LOCK THREAD). A POSSIBLE CAUSE FOR THE CHIP FORMATION WHEN INSERTING THE SCREW MAY BE THE DAMAGED ENEMA OF THE PRIME-LOCK THREAD OF THE RETAINING SLEEVE. THE DAMAGE MAY HAVE LEAD TO AN IMPROPER JOINT BETWEEN RETAINING SLEEVE AND SCREW WAS WHAT LED TO AN OVERLOAD ON THE EDGE OF THE BONE SCREW AND THE CHIP WAS SOLVED. THE CAUSE FOR THE DAMAGED THREAD SIDE CANNOT BE DETERMINED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS ON 2 SCREWS OF UNKNOWN LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282989 PEDIC-SCR-MATR Ø7 PERF L55 TAN NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1