BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9.0MM TI SIDE-OPENING SCREW 50 MM

    MDR report key: 3900642 · Received June 27, 2014

    Report

    Report Number
    2520274-2014-12224
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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. 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

    IT WAS REPORTED THAT A PATIENT HAD A T9-S1 POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINE SYSTEM (USS) ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAD BACK PAIN AND FELT THE RODS BREAK ON AN UNKNOWN DATE. THE PATIENT SAW THE SURGEON WHO ASSESSED THAT THE PATIENT HAD BROKEN RODS BETWEEN L4-5 ON THE RIGHT SIDE AND L3-4 ON THE LEFT SIDE. THE REVISION PROCEDURE WAS COMPLETED ON (B)(6) 2014. THE SURGEON CONFIRMED THAT THE PATIENT HAD NONUNIONS FROM L3-S1. IT WAS REPORTED THAT THE RIGHT ROD WAS BROKEN JUST CAUDAL (POSTERIOR) TO THE L4 SCREWS AND THE LEFT ROD WAS BROKEN JUST CRANIAL TO THE L4 SCREW. THE SURGEON REMOVED THE BROKEN RODS AND REPLACED ALL THE USS SCREWS EXCEPT THE LEFT L1, L2, L3 SCREWS, AND RIGHT L3 FROM THE PREVIOUS SURGERY. THE SURGEON PLACED NEW RODS AND CONNECTED THEM SUCCESSFULLY. THE SURGEON THEN PLACED ILIAC SCREWS AND CONNECTED THEM TO THE ROD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 8 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378218 9.0MM TI SIDE-OPENING SCREW 50 MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention