BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L45 T

    MDR report key: 2981174 · Received February 27, 2013

    Report

    Report Number
    2530088-2013-00225
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 29, 2013
    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. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NOT PREVIOUSLY REPORTED. ADDITIONAL CODES: MNI, MNH, KWP, KWQ. THE INVESTIGATION HAS SHOWN THAT THE HEAD OF THE PEDICLE SCREW HAS INDEED COME OFF. UNFORTUNATELY WE ARE NOT ABLE TO UNDERSTAND HOW THIS COULD HAPPEN; THEREFORE WE ARE NOT ABLE TO ELABORATE THE EXACT REASON WHICH HAS LED TO THIS PHENOMENON. FURTHER INVESTIGATIONS CONCERNING THE MANUFACTURING- AND MATERIAL RECORDS REVEALED THAT THE PRESENT ARTICLE CONFORMS TO THE SPECIFICATIONS. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING A PANGEA PROCEDURE AFTER SCREW PLACEMENT THE GOLD INNER PART OF ONE OF THE SCREW DISCONNECTED FROM THE SCREW HEAD. THIS HAPPENED AFTER THEY USED THE ALIGNMENT TOOL. THE SURGEONS REMOVED THE DAMAGED SCREW AND PLACED A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83629 PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L45 T SCREW NKB SYNTHES BRANDYWINE 7012897

    Patients

    Seq Age Sex Outcome Treatment
    1