BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI DUAL-OPENING SCREW 50MM THRD LENGTH F/6.0MM RODS

    MDR report key: 3984371 · Received August 6, 2014

    Report

    Report Number
    2520274-2014-12991
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT A T8-L2 POSTERIOR SPINAL FUSION WITH UNIVERSAL SPINAL SYSTEM DUAL OPENING WAS PERFORMED ON A PATIENT WITH A SPINE FRACTURE ON (B)(6) 2014. THE SURGEON INSTRUMENTED THE PATIENT FROM T8-L2 AND CONNECTED THE RODS. THE SURGEON TORQUED ALL NUTS AND COLLAR AND BEGAN REMOVING ALL THE HOOK/ SCREW HOLDERS USING A SMALL HEXAGONAL SCREWDRIVER .WHEN LOOSENING THE HOOK/ SCREW HOLDER FROM THE RIGHT L2 DUAL OPENING UNIVERSAL SPINAL SYSTEM SCREW THE TIP OF THE HOOK/ SCREW HOLDER BROKE OFF IN THE SCREW. THE SURGEON ELECTED TO NOT REMOVE THE SCREW LEAVING THE FRAGMENT IN THE SCREW, A PIECE REMAINED IN THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAYS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461446 7.0MM TI DUAL-OPENING SCREW 50MM THRD LENGTH F/6.0MM RODS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR