BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SNAP-ON OPEN PARALLEL CONNECTOR 6.0MM/6.0MM W/2 SCR

    MDR report key: 4100944 · Received September 19, 2014

    Report

    Report Number
    2530088-2014-10278
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 18, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS INDICATE THAT THE PRODUCT LOT WAS MANUFACTURED IN ACCORDANCE WITH ALL ESTABLISHED REQUIREMENTS WITH NO NONCONFORMITIES REPORTED. THE PRODUCT LOT UNDERWENT ALL SPECIFIED INSPECTION REQUIREMENTS, WHICH INCLUDE CAPTIVATION TESTING OF THE SCREW COMPONENT, WITH NO PRODUCT NONCONFORMITIES REPORTED. DEVICE HISTORY RECORDS FOR THE RAW MATERIAL LOT FURTHER INDICATE THAT THE RAW MATERIAL UNDERWENT ALL SPECIFIED INSPECTION AND TESTING REQUIREMENTS AND WAS FOUND TO MEET ALL ESTABLISHED CRITERIA FOR ACCEPTANCE AND USE AS INTENDED WITH NO NONCONFORMITIES REPORTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UNKNOWN MONTH, UNKNOWN DAY, 1955. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, AND KWP. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT ALL THE IMPLANTS SHOW NORMAL TRACES OF USE AND DO NOT SHOW ANY VISUAL EXCESSIVE DETECTABLE DETERIORATION OR NON CONFORMITIES. WITHOUT X-RAYS IT IS NOT POSSIBLE TO UNDERSTAND THE COMPLAINT.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CONNECTORS CAME LOOSE FROM THE RODS. POST-OPERATIVELY TWO SNAP-ON CONNECTORS HAVE LOOSENED AND ONE OF THEM HAS MIGRATED. AN EXISTING UNIVERSAL REDUCTION SCREW CONSTRUCT WAS EXTENDED USING THE SNAP-ON CONNECTORS TO CONNECT TO A NEW UNIVERSAL SPINE SYSTEM VARIABLE AXIS SCREW II POLY CONSTRUCT. AFTER A FEW MONTHS, THE PATIENT RETURNED FOR ROUTINE POST-OPERATIVE CHECK. X-RAY SHOWED BOTH CONNECTORS HAD COME LOOSE FROM THE RODS. ONE CONNECTOR DISLODGED FROM BOTH RODS AND WAS FREE IN THE SURROUNDING MUSCLE TISSUE; THE CONTRALATERAL SIDE CONNECTOR WAS STILL CONNECTED TO THE CRANIAL CONSTRUCT. UPON REVISION SURGERY THIS WAS CONFIRMED AND BOTH CONNECTORS WERE REMOVED AND REPLACED BY A DIFFERENT UNIVERSAL SPINE SYSTEM CONNECTOR. THE SURGEON NOTICED THAT BOTH SCREWS FROM ONE OF THE CONNECTORS COULD BE TIGHTENED MORE THAN 1.5 FULL TURNS; THIS INDICATION THE CONNECTOR WAS ALMOST AT ITS MOST LOOSENED STATE. THE SETSCREWS OF THE PARTIALLY CONNECTED CONNECTOR COULD ONLY BE TIGHTENED 0.5 TURNS. THE SURGEON STATES TIGHTENED BOTH CONNECTORS WITH THE TORQUE LIMITING HANDLE INDICATED IN THE SURGICAL TECHNIQUE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584249 TI SNAP-ON OPEN PARALLEL CONNECTOR 6.0MM/6.0MM W/2 SCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 7236290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention