BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 8040716 · Received November 6, 2018

    Report

    Report Number
    1030489-2018-01449
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 15, 2018
    Report Date
    March 25, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART CONTAINS 4 SET SCREWS OF PART# 6430530. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER, A LIKE DEVICE WITH PART# 6430530, 510K# K143375 AND UPN (B)(4) IS AVAILABLE FOR USE IN THE US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND OPTICAL INSPECTION CONFIRMED THE BREAK OFF PORTION OF THE SET SCREW WAS RETURNED. THE THREADED PART OF THE SET SCREW IS MISSING. UNABLE TO DETERMINE ROOT CAUSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE: POSTERIOR FUSION AFTER OBLIQUE LUMBAR INTERBODY FUSION (OLIF) IT WAS REPORTED THAT INTRA-OP, WHEN TRYING TO PERFORM FINAL TIGHTENING FROM ONE SIDE OF L3, IT COULD NOT BE THREADED BECAUSE OF IDLE. EVEN THOUGH THE SCREW AND SET SCREW WERE REPLACED, IT WAS THE SAME. WHEN INSERTING THE SET SCREW, A LITTLE SQUEAK SOUND WAS HEARD. COUNTER TORQUE WAS USED. PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881091 CD HORIZON SOLERA SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0648954W

    Patients

    Seq Age Sex Outcome Treatment
    1