BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8901881 · Received August 16, 2019

    Report

    Report Number
    1030489-2019-00910
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    April 12, 2018
    Report Date
    August 16, 2019
    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
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS/SCREWS HAVE BEEN USED IN THE SURGERY: PART# 55840006550; LOT# UNKNOWN; 510K# K113174; UDI# (B)(4); QTY# 2 PART# 55840006555; LOT# UNKNOWN; 510K# K113174; UDI# (B)(4); QTY# 1 PART# 55840006545; LOT# UNKNOWN; 510K# K113174; UDI# (B)(4); QTY# 6 THE QUANTITIES OF THE SCREWS WHICH LOOSENED IS NOT CONFIRMED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: PSEUDOARTHROSIS. HARDWARE FAILURE. HE UNDERWENT THE FOLLOWING PROCEDURES 1. FUSION EXPLORATION, 2. REMOVAL OF L1 PEDICLE SCREWS AND RODS, 3. L1-4 POSTERIOR ARTHRODESIS, 4. MORSELIZED BONE ALLOGRAFT USE, 5. HEMOVAC DRAIN PLACEMENT. AS PER OPERATIVE NOTES" THE PATIENT PRESENTED FOR RIGHT HIP REPLACEMENT DUE TO FELL DOWN. THE MEDICAL RECORDS IN CONNECTION WITH THIS FALL NOTE THAT PATIENT HAD BEEN SUFFERING FROM A RIGHT PARAVERTEBRAL LUMP "MOST LIKELY SECONDARY TO L1 PEDICLE SCREWS LOOSENINGS WHICH WAS IMPLANTED ON (B)(6) 2017", LOOSENING CONTRIBUTED TO CAUSE HIM TO FALL AND ONGOING PAIN, WEAKNESS IN HIS LOW BACK AND SUSTAIN THE RESULTING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694540 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other