BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM HEXALOBE SET SCREW

    MDR report key: 3241305 · Received July 22, 2013

    Report

    Report Number
    2027467-2013-00019
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    NKB
    PMA / PMN Number
    K123623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); SACRAL CANNULATED POLYAXIAL SCREW 6.5MM X 35MM, TI - LOT 654025 MANUFACTURED 7/20/2012. THE SUSPECT DEVICES ARE IN ROUTE FROM THE INTERNATIONAL CUSTOMER. UPON RECEIPT THE IMPLANTS WILL BE EVALUATED AND A FOLLOW-UP SUBMISSION PROVIDED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE FOUND NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE IMPLANTS WERE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. SINCE THE SET SCREW LOOSENING WAS FOUND DURING X-RAYS TAKEN ON (B)(6) 2013 IT IS ASSUMED THAT A SUCCESSFUL FUSION HAD NOT OCCURRED. NO X-RAYS HAVE BEEN PROVIDED FOR EVALUATION. THE PATIENT AGE OR ANY INFORMATION ON A PRIOR SURGERY PERFORMED HAS NOT BEEN PROVIDED. FIGURE 1 SHOWS THE TWO SET SCREWS AVAILABLE FOR EVALUATION. THE LEFT SET SCREW SHOWS THE INDENTATION MARK TYPICALLY SEEN AS A RESULT OF CONSTRUCT TIGHTENING USING THE TORQUE LIMITING DRIVER. THE RIGHT SET SCREW DOES NOT SHOW ANY INDENTATION MARKS. THIS COULD BE A RESULT OF IMPROPER FINAL TIGHTENING OF THE CONSTRUCT WHICH COULD BE THE CAUSE FOR SET SCREW LOOSENING. FIGURE 2 SHOWS THE FRACTURED SCREW AVAILABLE FOR EVALUATION. THERE ARE NO PRIOR SIMILAR FAILURE MODES REPORTED. THIS FAILURE COULD ALSO BE CONNECTED TO THE SET SCREW LOOSENING DUE TO IMPROPER FINAL CONSTRUCT TIGHTENING WHICH RESULTED IN UNUSUAL FORCES ON THE SACRAL SCREW AND HENCE FRACTURED THE SCREW HEAD. IMPROPER FINAL TIGHTENING OF THE CONSTRUCT IS ONLY AS ASSUMPTION, AND HENCE UNKNOWN CLINICAL FACTORS/CIRCUMSTANCES RELATED TO EITHER THE PATIENT OR PROCEDURE CAUSED THE SCREWS TO FRACTURE. DURING REVISION SURGERY ON (B)(6) 2013 THE ADJUSTABLE BRIDGE THREADS STRIPPED. THIS COULD BE A RESULT OF OVER-TIGHTENING OR IMPROPER USE OF SURGICAL TECHNIQUE. HENCE, UNKNOWN CLINICAL FACTORS/CIRCUMSTANCES RELATED TO PROCEDURE MAY HAVE CAUSED THE ADJUSTABLE BRIDGES TO FAIL. AT THIS POINT, IT IS INDETERMINATE.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICES HAVE BEEN RETURNED FROM THE INTERNATIONAL CUSTOMER AND ARE CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED A PATIENT RETURNED TO PHYSICIAN COMPLAINING OF PAIN. X-RAYS TAKEN (B)(6)2013 REVEALED ONE SET SCREWS HAD BECOME DETACHED FROM THE CONSTRUCT. REVISION SURGERY WAS PERFORMED (B)(6) 2013 AT WHICH TIME IT WAS DISCOVERED THAT A SACRAL SCREW LOCATED IN THE S1 HAD FRACTURED AND BROKE. DURING THE REVISION THE FRACTURED SCREW, DETACHED SET SCREW AND ROD WERE REMOVED AND REPLACED WITH A NEW HARDWARE. TO INCREASE STABILITY AN ADJUSTABLE BRIDGE WAS ADDED TO THE CONSTRUCT. WHILE ATTACHING THE BRIDGE A PIECE OF THE THREADS SEPARATED RENDERING THE DEVICE USELESS. THE SLIVER WAS RECOVERED AND THE BRIDGE REMOVED AND REPLACED WITHOUT ISSUE. THE ILLICO POSTERIOR FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341792 TITANIUM HEXALOBE SET SCREW NKB, MNH, MNI NKB ALPHATEC SPINE INC 22015 647735

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention