BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L50 T

    MDR report key: 2895684 · Received January 3, 2013

    Report

    Report Number
    2530088-2013-00005
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PRESENT PEDICLE SCREW WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. ALSO WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS LOT. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE COMPLAINT DESCRIPTION WE ASSUME THAT A LATERAL TIPPING OF THE REMOBILIZATION INSTRUMENT WHILE THE HANDLE WAS SQUEEZED CAUSED THIS OCCURRENCE. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE WITH PANGEA, THE SURGEON WAS NOT ABLE TO PUT THE ROD IN PLACE BECAUSE THE GOLDEN RING INSIDE THE SCREW HEAD WAS OUT OF PLACE. THE SURGEON REMOVED THE SCREW AND REPLACED THE SCREW WITH ANOTHER NEW SCREW. NO PATIENT HARM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468 PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L50 T PEDICLE SCREW NKB SYNTHES BRANDYWINE 6952151

    Patients

    Seq Age Sex Outcome Treatment
    1