BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 8920259 · Received August 22, 2019

    Report

    Report Number
    1030489-2019-00930
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    May 14, 2019
    Report Date
    August 22, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED PRODUCT IS A MULTI-PACK WHICH CONTAINS FOUR DEVICES WITH PART# 6430530. THIS PRODUCT IS NOT AVAILABLE FOR MARKET IN THE US. HOWEVER, A LIKE DEVICE WITH PART# 6430530, 510K# K143375 AND UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT ANALYSIS RESULTS: VISUAL INSPECTION CONFIRMED THE BREAK OFF PORTION OF THE SCREW WAS RETURNED STILL ATTACHED TO THE RETAINING DRIVER. ONCE REMOVED OPTICAL INSPECTION REVEALED THE INNER HEX OF THE SCREW HAS BEEN STRIPPED. THE EDGES HAVE BEEN DEFORMED AND ROUNDED OFF. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TYPE OF PROCEDURE OR TECHNIQUE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS IMPLANTED: L5/S IT WAS REPORTED THAT INTRA-OP, AFTER BREAKING OFF THE SET SCREW, THE PLUG OF THE SET SCREW WAS STUCK IN THE DRIVER AND COULD NOT BE TAKEN OUT. ALSO, THE SETSCREW WAS FOUND TO BE STRIPPED. AFTER THE OPERATION, IT WAS TRIED AGAIN AT AN UNSTERILIZED PLACE, BUT THE SET SCREW COULD NOT BE TAKEN OUT EITHER. PATIENT SYMPTOMS OR COMPLICATIONS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716497 CD HORIZON SOLERA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0669897W

    Patients

    Seq Age Sex Outcome Treatment
    1