BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8040816 · Received November 6, 2018

    Report

    Report Number
    1030489-2018-01458
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 20, 2018
    Report Date
    March 8, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 55811015540, 510K #K122433 AND UDI # (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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL EXAMINATION OF THE MAS BONE SCREW CONFIRMED BONE SCREW COMPLETE FRACTURE AT APPROXIMATELY 3 THREADS FROM THE BASE OF THE BONE SCREW HEAD. MICROSCOPIC EXAMINATION DID NOT IDENTIFY MATERIAL DEFECT NEAR THE AREA OF FRACTURE, WHICH COULD CONTRIBUTE TO CRACK PROPAGATION. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED GENTLY CURVING CONVEX STRIATIONS THROUGHOUT THE CROSS-SECTIONAL AREA OF THE IMPLANT, WHICH IS INDICATIVE OF CYCLIC FATIGUE UNTIL SUBSEQUENT MECHANICAL FAILURE OF THE SCREW. DIMENSIONAL INSPECTION OF MAJOR DIAMETER CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OF THE IMPLANT COMPONENTS. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT AN UNSPECIFIED SURGERY USING SAS SCREW. POST-OP, PATIENT SUFFERED WITH BURST TRAUMA AT TH12 AND HENCE CORRECTION WAS PERFORMED WITH TRAUMA DEVICE. AFTER PERFORMING FUSION AT TH11/L1, THE SCREW AT LEFT L1 WAS FOUND TO BE BROKEN INTRA-OPERATIVELY. THE BREAKAGE WAS UNKNOWN BEFORE THE OPERATION, AND IT TURNED OUT TO BE BROKEN DURING THE OPERATION OF SCREW REMOVAL AFTER BONE FUSION ACHIEVED. THE TIP OF THE SCREW REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882145 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1