BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2132731 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00754
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    August 15, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K052747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FUNCTIONAL CHECK HAS BEEN PERFORMED ON THE RETURNED INSTRUMENT, AND THE SLEEVE DIDN'T LOOSE THE MAS. IN ADDITION, NO DEFECT WAS FOUND ON THE RETURNED INSTRUMENT THAT CAN BE RESPONSIBLE OF THE EVENT. THE SLEEVE AND EXTENDER ASSEMBLY MAY LOOSE THE BONE SCREW IF LATERAL LOADS ARE APPLIED ON THE SLEEVE WHILE THE EXTENDER WAS ALREADY PARTIALLY REDUCED. THE ORIGIN OF THE LATERAL LOAD MAY COME FROM ONE OF THE FOLLOWING CONFIGURATIONS: THE SLEEVE WAS NOT FIXED CORRECTLY TO THE HEAD OF THE BONE SCREW. THE ARMS OF THE SLEEVE WOULD NOT BE PARALLEL PREVENTING FROM A GOOD SLIDING OF THE EXTENDER RESULTING IN LATERAL LOADS AGAINST THE SLEEVE. THE ROD IS PINCHED BETWEEN THE SLEEVE AND THE EXTENDER DURING THE REDUCTION, RESULTING IN LATERAL LOADS AGAINST THE SLEEVE. NO DEFECT WAS FOUND ON THE RETURNED INSTRUMENT THAT CAN CONFIRM ONE OF THE AFOREMENTIONED HYPOTHESIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE. DURING REDUCTION, THE SCREW EXTENDER DETACHED FROM THE BONE SCREW. THE BONE SCREW HAD TO BE REPLACED AND A NEW SCREW EXTENDER WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. FA11B003

    Patients

    Seq Age Sex Outcome Treatment
    1