BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 IMPLANTS, S4 POLYAXIAL SCREW

    MDR report key: 1299283 · Received December 2, 2008

    Report

    Report Number
    3005673311-2008-00029
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    July 29, 2008
    Report Date
    October 15, 2008
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWP
    PMA / PMN Number
    K032219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING S4 IMPLANTS DEVICES WERE INVOLVED IN THE REPORTED EVENT: MODEL NUMBER: SW787T; BRAND NAME: S4 POLYAXIAL SCREW 7.0X50MM; LOT NUMBER: 51313451 (QTY:1); LOT NUMBER: 51281607 (QTY: 1). MODEL NUMBER: SW788T; BRAND NAME: S4 POLYAXIAL SCREW 7.0X55MM; LOT NUMBER: 51241570; QTY: 1. MODEL NUMBER: SW777T; BRAND NAME: S4 POLYAXIAL SCREW 6.0X50MM; LOT NUMBER: 51402958; QTY: 1. MODEL NUMBER: SW656T; BRAND NAME: S4 PRE-BENT ROD, 5.5X45MM; LOT NUMBER: 51459506; QTY: 1. MODEL NUMBER: SW790T; BRAND NAME: S4 SET SCREW NEW VERSION; LOT NUMBER: 51413114 (QTY: 1), LOT NUMBER: 51345301 (QTY: 1), LOT NUMBER: 51477480 (QTY: 1), LOT NUMBER: 51416722 (QTY: 1). DEVICES WILL BE FORWARDED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    POSTERIOR L4 - S1 LUMBAR INSTRUMENTED FUSION SCREWS DISASSEMBLED ON MANIPULATION DURING INSTALLATION. THE PATIENT SELECTED FOR IMPLANTATION HAD DDD AND NEURAL FORAMINAL COMPRESSION FROM L4 - S1 AND VERTEBRAL COLLAPSE ON THE RIGHT SIDE OF L5. DUE TO PATIENT ANATOMIC STRUCTURES, THE IMPLANTED S4 SCREWS REMAINED MISALIGNED. THE SURGEON ATTEMPTED TO USE A PRE-LORDOSED 45 MM ROD WITH THE CONCAVE SIDE FACING MEDIALLY TO CAPTURE THE MISALIGNED SCREWS. UPON MANIPULATION OF THE POLYAXIAL HEADS, ROD, AND PATIENT ANATOMY, NO SUCCESS WAS ACHIEVED. THE SURGEON FOUND THAT THE DEGREES OF FREEDOM OF THE POLYAXIAL WERE REDUCED UPON APPLICATION OF THE ROD. IN THE PROCESS OF ATTEMPTING TO CAPTURE EACH SCREW WITH THE ROD, THE POLYAXIAL HEADS WERE MANIPULATED AND SOME "FELL APART". THE SURGEON REMOVED ALL OF THE HARDWARE AND REPLACED. NO INJURY WAS REPORTED. DELAY TIME IS UNKNOWN AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S4 IMPLANTS, S4 POLYAXIAL SCREW KWP AESCULAP AG & CO. KG SW784T 51478423

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other