BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LGTH

    MDR report key: 3080395 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10478
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    November 9, 2011
    Report Date
    November 9, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS 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 DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE DHR SHOWED THERE WERE 100 PERCENT VISUAL INSPECTIONS FOR NONCONFORMITIES AND 100 PERCENT FULL FUNCTIONALITY TESTS. THE PRODUCT EVALUATION AND VISUAL INSPECTION REVEALED THAT THE SCREW SUBCOMPONENTS ARRIVED FULLY DISASSEMBLED FROM EACH OTHER WITH MODERATE SCRATCHING ON THE CORNERS OF THE ASSEMBLY RETENTION FEATURES. THE IMPLANTATION TECHNIQUE AT THE TIME OF THE EVENT IS UNKNOWN AND NO OTHER INSTRUMENTS WERE RETURNED WITH THE IMPLANT. THE LOCATION OF THE GROOVES AND INDENTATIONS IN THE INTERIOR OF THE COLLET COMPONENT SUGGESTS THAT THE COLLET WAS FORCED UP AGAINST THE GROOVES ON THE BONE SCREWS UPPER SPHERICAL RIM. IT IS POSSIBLE THAT THE USER MAY HAVE DONE THIS BY DRIVING THE SCREW INTO THE BONE UNTIL THE POLYAXIAL HEAD WAS LAGGED TIGHTLY AGAINST THE CORTICAL SURFACE OF THE BONE. THIS MIGHT HAVE PRE-LOCKED THE ANGULATION. IN THIS CONDITION THE BODY COMPONENT MAY HAVE BEEN ROTATED RELATIVE TO THE LOCKED COMPONENTS WHICH COULD MAKE THE SCREW MORE SUSCEPTIBLE TO DISASSEMBLY. CONCLUSION - WITH SO LITTLE KNOWN ABOUT THE IMPLANTATION TECHNIQUE DURING THIS EVENT AND WITHOUT THE MATING INSTRUMENTS FURTHER EVALUATION IS NOT POSSIBLE. A DEFINITE CAUSE FOR THIS COMPLAINT HAS NOT BEEN IDENTIFIED AND THERE IS NO APPARENT INDICATION THAT THERE IS A DESIGN-RELATED ISSUE WITH THIS IMPLANT. AS SUCH, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    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. THE MANUFACTURING EVALUATION REVEALED THE ASSEMBLY WAS DISASSEMBLED INTO COMPONENTS. THE BODY HAD VISIBLE WITNESS LINE IN IDENTIFICATION (ID) SHOWING ASSEMBLY PATH OF SLEEVE AND DAMAGE / SCRATCHES IN THE DOVETAIL AREA. THE SCREW HAD DAMAGE TO THE T25 STARDRIVE INTERNAL AREA AND HAD COMPRESSED GROOVES ON THE HEAD. THE COLLET HAD GALLING AND SCREW HEAD IMPRINT ON THE SPHERICAL ID. THE SLEEVE HAD DAMAGE AND MARKS/SCRATCHES TO THE OUTSIDE DIAMETER AND THE 9.7MM DIAMETER FEATURE THAT LOCKS WITH THE BODY. ALL DESCRIBED NONCONFORMITIES WOULD BE POST MANUFACTURING. DAMAGED SCREW HEAD AND COLLET HAVING DIMENSIONS THAT ARE UNOBTAINABLE IN MANUFACTURED SPLIT CONDITION; COMPLAINT IS INDETERMINATE. ORIGINAL AWARENESS DATE IS (B)(4) 2011, NEW INFORMATION WAS RECEIVED ON 02/10/2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DISENGAGING THE SCREWDRIVER FROM THE PEDICLE SCREW FOR AN L5-S1 PLIF, POSTERIOR LUMBAR INTERBODY FUSION, THE GOLD RING IN THE PEDICLE SCREW CAME OUT. THE SURGEON REMOVED THIS SCREW AND REPLACED IT WITH ANOTHER SCREW. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182657 7.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LGTH NKB SYNTHES BRANDYWINE 6489591

    Patients

    Seq Age Sex Outcome Treatment
    1