BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6816095 · Received August 24, 2017

    Report

    Report Number
    1030489-2017-01955
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    August 4, 2017
    Report Date
    April 18, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440130, 510K # K102555 AND UPN (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THERE WERE TWO SET SCREWS RETURNED. THE FIRST SCREW, PLI10 DOES NOT SHOW ATYPICAL WITNESS MARKS AROUND THE FACE OF THE SET SCREW OR ATYPICAL DEFORMATION TO THE NODE. IT IS POSSIBLE THAT THIS SET SCREW DID NOT LOOSEN TILL AFTER PLI20 BACKED OUT. THE SECOND SCREW, PLI20 DOES HAVE A WITNESS MARK AROUND THE NODE ON THE SCREW FACE. THIS WITNESS MARK IS CONSISTENT WITH THE ROD NOT BEING FULLY REDUCED WHEN THE SET SCREW IS INSTALLED. THIS CONDITION CAN CAUSE THE BREAK OFF PORTION OF THE SET SCREW TO RELEASE BEFORE THE ROD IS FULLY SEATED IN THE SADDLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: KYPHOSIS, LUMBAR SPONDYLOLISTHESIS LEVELS IMPLANTED: T9/S2AI IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE. POST-OP, THE PLACED NUT CAME OFF. RE-OPERATION WAS SCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596088 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5344400

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention