BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3181241 · Received June 21, 2013

    Report

    Report Number
    2530088-2013-00974
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 8, 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

    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 HAS BEEN REQUESTED. THE VISUAL INVESTIGATION HAS SHOWN THAT THE 3D SCREW HEAD IS NOT DAMAGED, HOWEVER, A LARGE PART OF THE PEDICLE SCREWS PRIME LOCK INTERFACES HAD BROKEN OFF. THE INVESTIGATION REVEALED PRODUCTION AND MATERIAL DOCUMENTS SUPPORT THAT THE PEDICLE SCREW HAS BEEN MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. A VERY LIKELY CAUSE FOR THE SCREW BECOMING DETACHED IS THE DAMAGE OF THE BONE SCREWS EDGE, THIS EDGE IS IMPORTANT FOR SECURING THE SCREW HEAD. THE DAMAGE OF THE SCREW BONES EDGE HAS PROBABLY BEEN CAUSED BY THE FACT THAT THE RETAINING SLEEVE HAD NOT BEEN TIGHTENED FIRMLY ENOUGH IN THE PRIME LOCK THREAD AND/OR THAT THE PRIME LOCK SCREW CONNECTION BECAME LOOSENED WHEN INSERTING THE SCREW DUE TO A HIGHER FRICTION BETWEEN THE EXTERNAL AND INTERNAL RETAINING SLEEVE. THIS IN COMBINATION WITH THE GREAT LATERAL FORCES ONTO THE SCREW DUE TO THE TENSION OF THE SOFT PART COULD HAVE LED TO THE OBSERVED DAMAGE. THE PRODUCTS HAVE BEEN MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS THIS COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE. (B)(6).

    Additional Manufacturer Narrative · 1

    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 PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THE SCREW DETACHED FROM THE SCREWDRIVER AND THE 3D HEAD FROM THE BONE SCREW WHEN SCREWING IN THE SCREW. THE HEAD WAS LATER PUT ON. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL ATTEMPTS REVEALED THAT NO FURTHER INFORMATION IS AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281978 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES BRANDYWINE 6904257

    Patients

    Seq Age Sex Outcome Treatment
    1