BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREW-SOLID 7.5X40MM

    MDR report key: 3901729 · Received May 5, 2014

    Report

    Report Number
    3004608878-2014-00050
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 18, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    HWC
    PMA / PMN Number
    K091266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETE ON 04/18/2014: METHOD: REVIEW OF DEVICE HISTORY RECORD. INTEGRA COMPLAINT MANAGEMENT DATABASE WAS REVIEWED FOR SIMILAR COMPLAINTS. VISUAL INSPECTION. RESULTS: DEVICE HISTORY REVIEW FOR LOT 14507 MET ALL SPECIFICATIONS WITH NO ASSOCIATED NONCONFORMANCE'S SPECIFIC TO THE PRODUCT ISSUE. IN THE PAST 12 MONTHS THERE ARE (B)(4) ADDITIONAL COMPLAINTS FOR SIMILAR EVENTS. NO CAPAS HAVE BEEN INITIATED AS THE RESULT OF FAILURES SPECIFIC TO THIS TYPE OF EVENT FOR THIS OR SIMILAR PRODUCTS FOR THE PAST 12 MONTHS. METHODS: THE CORAL POLY-AXIS SCREW (PN 18-12-7540, LOT 14507) WAS RETURNED AND EVALUATED. BASED ON THE APPEARANCE OF THE DEVICES, THE INNER RING APPEARED TO HAVE BROKEN AND SEPARATED FORM THE SCREW/TULIP ASSEMBLY. NO OTHER DEFECTS WERE OBSERVED ON THE SCREW OR TULIP. AFTER THE CORAL SCREWS ARE ATTACHED TO THE DRIVER, THE SCREW SEAT IS PROVISIONALLY LOCKED AND NEEDS TO BE RE-ANIMATED. LOADING AND UNLOADING SCREWS FORM THE DRIVER CAN THEREFORE POTENTIALLY DAMAGE THE INTERIOR RING. ADDITIONALLY, IF THE TORQUE TIP IS NOT ENGAGED WHEN THE DRIVER IS INSERTED INTO THE SCREW, THE DRIVER MAY NOT BE ALIGNED AND IF PRESSURE IS APPLIED, THE WILL NOT HOLD THE SCREW SHANK IN AXIAL ALIGNMENT AND WHEN PRESSURE EIS APPLIED THE RING CAN POTENTIALLY BREAK. CONCLUSION: BASED O THE AVAILABLE INFORMATION AND AN EVALUATION OF THE RETURNED DEVICES, A ROOT CAUSE CANNOT CONCLUSIVELY BE DETERMINED AS TO WHY THE INTERIOR RING ON BOTH SCREWS BROKE. SINCE THERE IS NO EVIDENCE TO SUGGEST A DESIGN OR MANUFACTURING DEFECT OCCURRED, AND THE OCCURRENCE OF SIMILAR EVENTS IS LOW, NO CORRECTIVE ACTIONS WILL BE INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED: A SCREW BROKE DURING LUMBAR ARTHODESIS SURGERY. THE SURGERY WAS COMPLETED WITHOUT INJURY TO THE PATIENT. A SPARE DEVICE WAS AVAILABLE THAT FUNCTIONED CORRECTLY. THE EVENT DID NOT EXTEND SURGERY TIME FOR MORE THAN 10 MINUTES. A POSTOPERATIVE X-RAY WAS PERFORMED WHICH CONFIRMED THERE WERE NO PARTS OF THE SCREW LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268345 POLYAXIAL SCREW-SOLID 7.5X40MM CORAL MIS HWC SEASPINE, INC. W14507

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR