BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION S-1 SPINAL GRAFT CONTAINMENT SYSTEM

    MDR report key: 5235206 · Received November 19, 2015

    Report

    Report Number
    9710627-2015-00005
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    September 21, 2015
    Report Date
    December 15, 2015
    Manufacturer
    INION OY
    Product Code
    OJB
    PMA / PMN Number
    K071810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONCERNING THE PATIENT AND DATES OF THE EVENT. IN ADDITION, INFORMATION WAS RECEIVED THAT A SIMILAR ADVERSE EVENT (GRAFT SUBSIDENCE AND SCREW FRACTURE) WAS OBSERVED IN POSTOPERATIVE FOLLOW-UP X-RAY WITH 4 OTHER PATIENTS AT THE SAME CLINICAL PRACTICE DURING (B)(6) 2015. ACCORDING TO INFORMATION RECEIVED, NONE OF THE PATIENTS HAVE HAD CLINICAL SYMPTOMS, E.G. PAIN. PATIENTS ARE AGES 22-67, FOUR FEMALES AND ONE MALE. ACCORDING TO RECEIVED INFORMATION, PATIENT OUTCOME IN ALL CASES IS GOOD. GRAFT SUBSIDENCE IS A KNOWN COMPLICATION IN ACDF PROCEDURE. INION S-1 PRODUCT PROVIDES A MORE DYNAMIC FIXATION THAN CONVENTIONAL METAL PLATE, BUT IT IS NOT INDICATED TO CARRY LOAD. THE OCCURENCE RATE OF SCREW BREAKAGE/FRACTURE POSTOPERATIVELY IS 0,4% TO DATE AND INCLUDING THESE CASES; AND OF A SIMILAR SYSTEM OUTSIDE THE USA 0,2%. THE INION S-1 DEVICES ARE GRAFT CONTAINMENT DEVICES, WHICH PROVIDE FIXATION AND ARE NOT INTENDED TO REPLACE HEALTHY TISSUES OR WITHSTAND THE STRESS OF FULL LOAD BEARING. THE DEVICES CANNOT PROVIDE LEVERAGE IN THE FIXATION CONSTRUCT. THE DEVICE SHALL BE USED IN CONJUNCTION WITH TRADITIONAL RIGID FIXATION (I.E. POSTERIOR INTERSPINOUS WIRING).

    Additional Manufacturer Narrative · 1

    GRAFT SUBSIDENCE IS A KNOWN COMPLICATION IN ACDF PROCEDURE. INION S-1 PRODUCT PROVIDES A MORE DYNAMIC FIXATION THAN CONVENTIONAL METAL PLATE, BUT IT IS NOT INDICATED TO CARRY LOAD. THIS IS THE FIRST CASE OF GRAFT SUBSIDENCE REPORTED TO INION IN CONNECTION WITH THE USE OF INION S-1 SYSTEM. THE OCCURRENCE RATE OF SCREW BREAKAGE POSTOPERATIVELY IS 0,08% BY END OF 2014 AND OF A SIMILAR SYSTEM OUTSIDE THE USA 0,2%. THE INION S-1 DEVICES ARE GRAFT CONTAINMENT DEVICES, WHICH PROVIDE FIXATION AND ARE NOT INTENDED TO REPLACE HEALTHY TISSUES OR WITHSTAND THE STRESS OF FULL LOAD BEARING. THE DEVICES CANNOT PROVIDE LEVERAGE IN THE FIXATION CONSTRUCT. THE DEVICE SHALL BE USED IN CONJUNCTION WITH TRADITIONAL RIGID FIXATION (I.E., POSTERIOR INTERSPINOUS WIRING).

    Description of Event or Problem · 1

    IN THE 8 WEEKS POST OP X-RAYS, SURGEON OBSERVED GRAFT SUBSIDENCE IN CONNECTION WITH ACDF PROCEDURE, WHERE INION S-1 PLATE AND SCREWS WERE USED AS GRAFT CONTAINMENT DEVICE. SCREWS WERE OBSERVED TO BE BROKEN BELOW THE PLATE FROM THE UPPER END OF THE PLATE. IN 2 WEEKS POST-OP PICTURES THE FIXATION HAD BEEN OBSERVED AS FINE. THE PATIENT WAS WEARING A HARD COLLAR FOR 3 WEEKS AFTER THE OPERATION. THE PATIENT HAS NOT HAD ANY SYMPTOMS, E.G. PAIN, BUT A REVISION SURGERY WAS CONDUCTED TO AVOID ANY COMPLICATIONS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767739 INION S-1 SPINAL GRAFT CONTAINMENT SYSTEM BONE SCREW OJB INION OY UNK 1407001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other