BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X9 L5°

    MDR report key: 6372069 · Received March 2, 2017

    Report

    Report Number
    3005180920-2017-00082
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    January 31, 2017
    Report Date
    March 2, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    PMA / PMN Number
    K133192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 02 FEBRUARY 2017 AND INCLUDES: THE SURGEON DID NOT USE THE TRIAL CAGES. HE TRIED TO IMPLANT THE CAGE AFTER CONFIRMING INTERVERTICAL HEIGHT WITH THE PADDLE DISTRACTOR. THE SURGEON DOWNSIZED TO AN 8MM CAGE BECAUSE HE WAS NOT ABLE TO INSERT THE 9MM ONE. NO INSTRUMENTS WERE USED EXTRACTED THE CAGE FROM THE BONE. THE SURGEON FOUND IMPLANT BREAKAGE BEFORE COMPLETELY INSERTING THE CAGE. BATCH REVIEW PERFORMED ON 28 FEBRUARY 2017. LOT 153177: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 MAY 2016. EXPIRATION DATE: 2021-04-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 01 MARCH 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE MECTALIF OBLIQUE CAGE ANALYSED IS DEFORMED. THE POSTERIOR AREA OF THE INTERFACE IS DEFORMED. THE THREAD NECESSARY FOR THE CONNECTION OF THE INSERTER IS DEFORMED ON ONE SIDE AND COMPLETE ON THE OTHER ONE. THE IMPLANT HAS COMPLETELY LOST HIS FUNCTIONALITY AND ALSO THE ASSEMBLING FEATURE WITH THE RELATED INSTRUMENTS. THERE ARE A LOT OF DEEP SCRATCHES ON THE IMPLANT IN PARTICULAR IN THE POSTERIOR AREA OF THE DEVICE. THE TITANIUM COATING IS DAMAGED IN DIFFERENT POINTS: IN THE LATERAL SURFACES, THERE ARE SOME VERTICAL CRACKS IN THE COATING IN PARTICULAR LOCATED NEAR THE LATERAL WINDOWS; IN THE TOP AND BOTTOM SURFACES, THERE ARE SOME HORIZONTAL CRACKS AND IN PARTICULAR NOT MORE THAN THE MID OF THE CAGE; IN THE INTERNAL CAVITY FOR THE BONEGRAFT, THERE ARE SOME COATING MISSING IN NEAR THE THREAD INTERFACE IN THE INTERNAL CAVITY FOR BONEGRAFT. THE COMPLAINT AND THE ADDITIONAL INFORMATION OF THE EVENT DESCRIBE THAT THE CAGE STUCK BETWEEN THE VERTEBRAL BODIES AND THAT IT'S NOT POSSIBLE TO INSERT THE IMPLANT DEEPER, SO IT'S NECESSARY TO REMOVE IT. IT HAS BEEN STATED THAT IT WAS DIFFICULT TO REMOVE THE IMPLANT. THE DAMAGING OF THE THREAD ON THE BACK SIDE SUGGEST THAT AFTER THE USAGE OF THE STANDARD INSTRUMENT WITH THE APPLICATION OF VERY HIGH FORCE UNTIL REACH THE DEFORMATION OF THE THREAD ITSELF. THE PRESENCE OF THE SCRATCHES ARE PROBABLY DUE TO THE USAGE OF OTHER GENERIC INSTRUMENT TO REMOVE THE IMPLANT FROM THE VERTEBRAL BODIES. THE PRESENCE OF THE CRACKS, IS PROBABLY DUE TO THE MEDIAL/LATERAL BENDING OR CRANIAL/CAUDAL BENDING AND THE CRACKS, SUGGEST THAT THE IMPLANT HAS BEEN INSERTED ONLY FOR THE HALF OF ITS LENGTH AND THEN IT HAS REMAINED STUCK. THE COATING MISSING, IS PROBABLY DUE TO AN EXTRA INSERTION OF AN INNER SHAFT OR SIMILAR INSTRUMENT AND A FOLLOWING APPLICATION OF LATERAL BENDING. IT HAS ALSO BEEN STATED THAT THE SURGEON DIDN'T USE THE TRIAL BEFORE THE DEVICE INSERTION. THE SKIP OF THIS STEP DIDN'T ALLOW TO CHECK THE CORRECT IMPLANT AND ALSO THAT THE IMPLANT COULD BE INSERTED. THE TRIAL COULD SUPPORT THE SURGEON DURING THE IMPLANT SELECTION AND COULD ALSO SHOW THE FINAL CONFIGURATION OF THE IMPLANT AND, DUE TO THE FACT THAT IT'S MADE OF TITANIUM, COULD GUARANTEED A BIGGER STIFFNESS AND STABILITY DURING THE INSERTION AND REMOVAL. IT'S DIFFICULT TO IDENTIFY A SPECIFIC ROUTE CAUSE FOR THIS EVENT. THE NUMBER OF SURGERY SUCCESSFULLY COMPLETED WITH THE SAME LOT (8) SUGGEST THAT THERE ARE NO OUT OF SPECIFICATION ON THIS LOT. THE MEAN ROUTE CAUSE COULD BE IDENTIFIED IN THE STEP OF SKIPPING THE TRIAL PHASE WHICH CAN EASILY RESULT IN A WRONG IMPLANT SELECTION IN TERMS OF HEIGHT AS WELL AS LENGTH.

    Description of Event or Problem · 1

    WHILE INSERTING THE SPINAL CAGE WITH THE HANDLE AND THE INNERSHAFT SHORT AT L4-5, THE INSERTER CONNECTION PART OF THE CAGE BROKE. THE SURGEON CHANGED TO AN 8MM HEIGHT IMPLANT, WHICH WAS SMOOTHLY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157257 MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X9 L5° INTERBODY FUSION DEVICE MAX MEDACTA INTERNATIONAL SA 153177

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other