BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 5364053 · Received January 13, 2016

    Report

    Report Number
    2520274-2016-10196
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 24, 2015
    Report Date
    December 24, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. ADDITIONAL DEVICE PRODUCT CODES ARE MNI, MNH, KWP, AND HWQ. THIS REPORT IS FOR ONE UNKNOWN USS C-CLAMP NUT. PART AND LOT NUMBERS WERE NOT PROVIDED BY THE REPORTER. OTHER¿UDI# IS UNAVAILABLE. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. REPORTING FACILITY PHONE NUMBER AND STREET ADDRESS ARE NOT AVAILABLE. 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

    SYNTHES (B)(4) REPORTED EVENTS IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO IMPLANT A UNIVERSAL SPINE SYSTEM (USS) TO TREAT A BURST FRACTURE AT LEVEL L2, IT WAS NOTED THAT THE TIP OF THE SMALL HEXAGONAL SCREWDRIVER WAS DAMAGED AND DID NOT FUNCTION AND THE C-CLAMP WAS DIFFICULT TO RELEASE. THE SURGEON WAS IMPLANTING THE USS FRACTURE SYSTEM IN ORDER AT LEVELS L1 AND L3. AFTER REDUCTION OF THE FRACTURE, FOLLOWED BY THE INSERTION OF SCREWS AT LEVELS L1 AND L3, TIGHTENING THE RODS AND GENERATING FIXATION WITH THE C-CLAMP WITH THE RING, THE SURGEON NOTED THE TIP OF THE SCREWDRIVER WAS DAMAGED AND DID NOT FUNCTION. THE SURGEON ALSO EXPERIENCED DIFFICULTY RELEASING THE C-CLAMP FROM THE PATIENT'S BONE. THE SURGEON HAD TO BREAK THE GOLD C-CLAMP NUT BY USING A POWER TOOL TO REMOVE THE CLAMP. THE SURGERY WAS EXTENDED FOR 40 MINUTES DUE TO THE REPORTED INSTRUMENT ISSUES. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS FOR ONE UNKNOWN USS C-CLAMP NUT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22913 APPLIANCE, FIXATION, SPINAL INTERLAMINAL NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 498.911, TI USS HALF RING FOR 6.0MM RODS