BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 3052002 · Received April 11, 2013

    Report

    Report Number
    2530088-2013-00596
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 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

    ADDITIONAL NARRATIVE: INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES VISUAL INSPECTION OF THE COMPLAINED DEVICES SHOWS NO DAMAGES AT THE SCREW HEAD BUT PRESENTS DAMAGES IN 40% OF THE PRIME LOCK THREAD. THE MOST POSSIBLE CAUSE FOR THE RELEASING OF THE SCREW HEAD IS THE DAMAGE OF THE HEAD OF THE BONE SCREW, WHICH HAS AN IMPORTANT FUNCTION IN RETAINING THE SCREW HEAD. MOST LIKELY, THIS DAMAGE WAS CAUSED BY A NOT SUFFICIENT ENGAGEMENT OF THE HOLDING SLEEVE (03.632.001 OR 03.632.036) INTO THE BONE SCREW PRIME LOCK AND/OR PRIME LOCK CONNECTION LOST ITS ENGAGEMENT WHEN THE FRICTION BETWEEN INNER AND OUTER TUBES OF THE HOLDING SLEEVE INCREASED DURING INTRA-OPERATIVE MANEUVERS. THESE TWO FACTORS, IN COMBINATION WITH HIGH LATERAL FORCES APPLIED ON THE SCREW DURING INSERTION, MIGHT HAVE LED TO SUCH DAMAGE. NO PRODUCT PROBLEM COULD BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT SERVICE: ADDITIONAL INFORMATION. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PART WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, THE HEAD OF THE SCREW CAME OFF AS THE SURGEON INSERTED THE MATRIX POLYAXIAL SCREW. THE SURGEON REMOVED THE SCREW AND IMPLANTED A NEW SCREW. THE SURGERY WAS COMPLETED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154190 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM NKB SYNTHES BRANDYWINE 8191793

    Patients

    Seq Age Sex Outcome Treatment
    1