BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.2MM TI DUAL-OPENING SCREW 50MM THRD LENGTH F/6.0MM RODS

    MDR report key: 4130631 · Received September 30, 2014

    Report

    Report Number
    2520274-2014-13855
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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, A PATIENT UNDERWENT SURGERY ON (B)(6) 2014 DUE TO BACK PAIN AND HARDWARE ISSUES. DURING THE SURGERY IT BECAME KNOWN THAT THE SCREWS AT T12 WERE PULLING OUT OF THE PEDICLES AND THE RODS WERE BROKEN BETWEEN L3 AND L4 BILATERALLY. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A USS CONSTRUCT FROM L4-S1 ON AN UNKNOWN DATE. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DAY IN (B)(6) 2013. DURING THE REVISION SURGERY, THE PATIENT WAS IMPLANTED WITH A USS CONSTRUCT DUAL OPENING FROM T12-L2 AND THE CONSTRUCT WAS CONNECTED TO THE EXISTING USS CONSTRUCT AT L4-S1 USING ROD CONNECTORS. DURING THE SURGERY ON (B)(6) 2014, ALL HARDWARE FROM THE ORIGINAL SURGERY AND THE REVISION SURGERY WERE REMOVED AND RE-INSTRUMENTED WITH SYNTHES USS FROM T10-S1. THIS IS REPORT NUMBER 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609400 5.2MM TI DUAL-OPENING SCREW 50MM THRD LENGTH F/6.0MM RODS ORTHOSIS, SPINAL PEDICLE NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention