BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 5331776 · Received December 29, 2015

    Report

    Report Number
    2520274-2015-18116
    Event Type
    Injury
    Date Received
    December 29, 2015
    Report Date
    December 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS ARE (B)(6). THIS REPORT IS FOR TWO (2) UNKNOWN PANGEA RODS. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE: MNI, MNH, KWP, AND KWQ. (OTHER): WITHOUT A VALID PART AND LOT NUMBER, A UDI IS NOT AVAILABLE. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN 2012. PER FACILITY, THE COMPLAINANT PARTS WILL NOT BE RETURNED FOR EVALUATION. (B)(4). UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT RODS WERE NOT PROVIDED. TWO POTENTIAL 510K NUMBERS INCLUDE: K090605 AND K082572. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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 DEVELOPED ADJACENT LEVEL DISC DISEASE REQUIRING AN EXTENSION/REVISION PROCEDURE. THE PATIENT WAS ORIGINALLY INSTRUMENTED WITH A PANGEA SPINE SYSTEM CONSTRUCT IN 2012 AT DISC LEVELS L4-S1. DUE TO THE ADJACENT LEVEL DISC DISEASE, THE PATIENT RETURNED TO THE OPERATING ROOM FOR REVISION ON (B)(6) 2015. THE CONSTRUCT WAS EXTENDED TO INCLUDE DISC LEVELS L3-L4. DURING THE PROCEDURE, THE SURGEON LEFT THE UNKNOWN PANGEA SCREWS FROM THE ORIGINAL PROCEDURE IN PLACE AT L4-S1. THE ORIGINAL TWO (2) RODS, HOWEVER, WERE REMOVED AND REPLACED WITH LONGER RODS. ALSO, TWO (2) ADDITIONAL SET SCREWS WERE PLATED AT THE L3-L4 LEVEL. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THIS REPORT IS FOR TWO (2) UNKNOWN PANGEA RODS. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855742 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention