BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 5374199 · Received January 18, 2016

    Report

    Report Number
    2520274-2016-10274
    Event Type
    Injury
    Date Received
    January 18, 2016
    Report Date
    December 23, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: UDI: PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN; UDI UNKNOWN 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

    ADDITIONAL NARRATIVE: PATIENT AGE AND WEIGHT NOT AVAILABLE FOR REPORTING. THE 510(K): REPORT IS FOR TWO (2) PARALLEL CONNECTORS THAT WERE LOOSE. ADDITIONAL PRODUCT CODES ¿ MNH, MNI, KWQ , KWP. ORIGINAL IMPLANT UNKNOWN . THE 510(K): K100952; WITHOUT A PART NUMBER, THE 510(K) NUMBER CANNOT BE CONFIRMED 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. MFR DATE: UNKNOWN. 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 WITH ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS) UNDERWENT SURGERY ON AN UNKNOWN DATE TO HAVE A MATRIX SPINE SYSTEM IMPLANTED. THE ORIGINAL MATRIX CONSTRUCT WAS IMPLANTED AT T2 THRU L4 DISC LEVELS. DURING A ROUTINE OFFICE VISIT THE SURGEON OBSERVED VIA X-RAY THAT THE PATIENT HAD TWO (2) LOOSE PARALLEL CONNECTORS AT THE T11 DISC LEVEL ON EACH SIDE. REVISION SURGERY WAS SCHEDULED AND COMPLETED ON (B)(6) 2015. DURING SURGERY, THE SURGEON REMOVED THE FOUR (4) RODS, TWO (2) LOOSE PARALLEL CONNECTORS AND ALL 30 MATRIX LOCKING CAPS. SURGEON LEFT THE MATRIX SET SCREWS IN PLACE. PATIENT WAS REVISED TO FOUR (4) NEW RODS, TWO (2) NEW PARALLEL CONNECTORS AT THE T11 DISC SPACE, AND ALL NEW LOCKING CAPS. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT STATUS WAS REPORTED AS ¿GOOD.¿ THIS REPORT IS FOR TWO (2) PARALLEL CONNECTORS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32922 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention