BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/50MM THRD LENGTH

    MDR report key: 3243567 · Received July 23, 2013

    Report

    Report Number
    2530088-2013-01086
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES - MNI, MNH, KWP, KWQ 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 HAVE BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ME: BOTH THE COLLET AND THE SLEEVE HAVE INADEQUATE SURFACE AREA FOR THE MATERIAL ANALYZER TO FUNCTION AND THE INTERNAL SPHERICAL DIAMETER FOR THE COLLET IS NOT A MEASUREABLE IN MANUFACTURED SPLIT CONDITION, COMPLAINT IS INDETERMINATE FORM A MANUFACTURING PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT EVALUATION: THE PANGEA SPINE SYSTEM INCLUDES POLYAXIAL PEDICLE SCREWS WITH VARIOUS LENGTHS AND DIAMETERS TO ACCOMMODATE PATIENT ANATOMY. THE CHU REVIEWED ASSEMBLY DRAWING FOR 04.620.650. THE DRAWING DETAILS THE APPROPRIATE DIMENSIONS, COMPONENTS, AND ETCHING INSTRUCTIONS FOR A SUCCESSFUL PEDICLE SCREW. IN THIS COMPLAINT, THE BODY DETACHED DURING CONSTRUCT ASSEMBLY. THE BODY CAN DETACH FROM THE BONE SCREW IF THE USER APPLIES A LOAD BEYOND THE DESIGN OF THE SCREW ASSEMBLY. THE COMPLAINT DESCRIPTION AND THE RETURNED IMPLANT DO NOT PROVIDE ENOUGH INFORMATION TO MAKE THIS DETERMINATION FOR A ROOT CAUSE.

    Description of Event or Problem · 1

    CONSULTANT REPORTED SURGEON WAS PERFORMING L4-S1 FUSION. HE HAD PLACED ALL THE SCREWS IN THE NORMAL FASHION WITH NO DIFFICULTIES. SURGEON THEN USED THE POLYAXIAL HEAD POSITIONER (03.620.015) TO ALIGN THE HEADS TO INSERT THE ROD. AFTER USING THE HEAD POSITIONER, HE NOTICED THAT A GOLD RING HAD COME UP OUT THE HEAD. HE THEN RETRIEVED THE GOLD RING WITH A BAYONETTE, REMOVED THE SCREW AND REPLACED IT WITH ANOTHER SAME SIZE SCREW. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344210 6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/50MM THRD LENGTH NKB SYNTHES BRANDYWINE 6560149

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR