BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 3953124 · Received July 23, 2014

    Report

    Report Number
    2520274-2014-12790
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 26, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR TWO UNKNOWN LOCKING CAPS/UNKNOWN LOTS. IMPLANT DATE: UNKNOWN. EXPLANT DATE: UNKNOWN; IT IS UNKNOWN IF THESE LOCKING CAPS WERE EXPLANTED OR REMAIN IN THE PATIENT. 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.

    Additional Manufacturer Narrative · 1

    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 REVISION EXPLORATION WAS PERFORMED OF A L3-S1 POSTERIOR LUMBAR FUSION DONE WITH MATRIX. THE PATIENT WAS COMPLAINING OF SIGNIFICANT LEG PAIN, ROUGHLY SEVEN WEEKS POST OPERATIVELY. UPON EXPLORATION THE SURGEON ELECTED TO REMOVE THE CAPS AND SACRAL SCREWS ON THE RIGHT AND LEFT AS WELL AS THE LEFT AND RIGHT L3 SCREWS. BOTH WERE UPSIZED AND REPLACED. THE SURGEON DETERMINED THE S1 SCREWS BILATERALLY WERE LOOSE, BUT HE WAS UNABLE TO DETERMINE IF THAT WAS THE REASON FOR THE LEG PAIN. THE SURGEON DECOMPRESSED THE NERVE COMPLETELY. A TOTAL OF FOUR SCREWS WERE REPLACED. THIS REPORT IS FOR TWO UNKNOWN LOCKING CAPS. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    THE LOCATION OF THE TWO LOCKING CAPS WAS REPORTED TO BE S1 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431504 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention