BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

    MDR report key: 4151100 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03903
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    December 22, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVIEW OF RADIOGRAPHIC IMAGES SHOW TWO X-RAY VIEWS AP AND LATERAL OF A CONSTRUCT FROM L4 TO S1. FENESTRATED SCREWS ARE SEEN IN PLACE WITH PURCHASE AUGMENTED WITH PMMA INJECTION THROUGH THE SCREWS AT BOTH L4 AND S1. BALLOON KYPHOPLASTY HAS BEEN PERFORMED AT L5. OSTEOPENIA IS PRESENT AS IS SEVERE DEGENERATIVE DISC COLLAPSE AT L4 AND L5. THERE APPEARS TO BE A CEMENT EXTRAVASATION ON THE LEFT AT L4. THERE IS ENOUGH ARTIFACT CREATED BY THE BARIUM/CEMENT MIXTURE AND THE IMPLANTS THAT I CANNOT VERIFY THAT THE S1 SCREWS ARE BROKEN.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL EXAMINATION OF THE MAS BONE SCREW CONFIRMED BONE SCREW FRACTURE AT THE BASE OF THE BONE SCREW HEAD. VISUAL AND OPTICAL INSPECTION OF THE BONE SCREW SURFACE IMMEDIATELY ADJACENT TO THE FRACTURE IDENTIFY MATERIAL DAMAGE WHICH APPEARS TO BE SECONDARY (POST-FRACTURE) DAMAGE. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED MULTIMODAL FRACTURE, WITH INITIAL FAIRLY FLAT REGION APPROXIMATELY 30% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, WITH EVIDENCE OF RATCHET MARKS, BEACH MARKS, PROGRESSIVE STRIATIONS, WHICH ARE ALL CONSISTENT WITH CYCLIC FATIGUE. THE REMAINING PORTION OF THE CROSS-SECTIONAL AREA. THIS IS FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION, CONSISTENT WITH OVERLOAD, AND WHICH APPEARS TO HAVE RESULTED IN ULTIMATE FAILURE OF THE IMPLANT. DIMENSIONAL INSPECTION CONFIRMS MAJOR AND MINOR DIAMETER ARE WITHIN PRINT SPECIFICATION. CONCLUSION: AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT; UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A PREVIOUS KYPHOPLASTY FOR AN L5 FRACTURE SUFFERED A COLLAPSE OF THE VERTEBRAL BODY AND REQUIRED ADDITIONAL SURGERY TO STABILIZE L4-S1. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY FROM L4-S1 WITH HARDWARE INSTRUMENTATION. THE PATIENT PRESENTED POST-OP WITH BACK PAIN. X-RAY DID NOT INDICATE ANY ISSUE. PATIENT UNDERWENT A REVISION AND IT WAS DISCOVERED THAT BOTH S1 SCREWS WERE BROKEN. THE HARDWARE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633563 CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS H5090865

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Other