BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI CURVED SOFT ROD 55MM

    MDR report key: 2549517 · Received April 18, 2012

    Report

    Report Number
    1719045-2012-00286
    Event Type
    Injury
    Date Received
    April 18, 2012
    Report Date
    March 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MNI
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LOT NUMBERS WERE RECEIVED. IT IS UNK AS TO WHICH LOG NUMBER IS ASSOCIATED WITH THE SUBJECT DEVICE. THE LOT NUMBERS ARE AS FOLLOWS: LOT #3639141 - QUANTITY OF 1. LOT # 3802768 - QUANTITY OF 1. DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH CLICK-X PEDICLE SCREW CONSTRUCT AT L3-L4 FOR DEGENERATIVE DISC DISEASE ON (B)(6) 2012. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. THE ROD ON THE RIGHT SIDE OF THE CONSTRUCT BECAME LOOSE AND MIGRATED OUT OF THE INFERIOR SCREW CAUSING THE OPAL SPACER TO MIGRATE BETWEEN THE DISC SPACE INTO THE VERTEBRAL CANAL. DURING THE REMOVAL OF THE LOCKING CAPS, SURGEON REPORTED THAT THE SCREWS ON THE RIGHT SIDE OF THE CONSTRUCT REQUIRED MINIMAL EFFORT TO REMOVE. SURGEON REMOVED ALL HARDWARE WITH THE EXCEPTION OF THE OPAL SPACER. SURGEON REVISED PT TO COMPETITOR'S HARDWARE AND REPOSITIONED THE OPAL SPACER. THE LEFT SIDE OF THE CONSTRUCT REMAINED INTACT. THIS IS THE 1ST OF 8 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI CURVED SOFT ROD 55MM 6.0MM CURVED SOFT ROD MNI SYNTHES MONUMENT 3639141 OR 3802768

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention LOCKING CAPS| SCREWS| OPAL SPACER| RODS| 3-D HEADS