BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 10389376 · Received August 11, 2020

    Report

    Report Number
    1030489-2020-01058
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 11, 2020
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIMILAR DEVICE WITH PRODUCT NUMBER (B)(4) WITH 510(K)# K040583 IS MARKETED IN US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR ANC HOR BREAKAGE AFTER IDIOPATHIC SCOLIOSIS FIXATION. IT WAS REPORTED THAT AFTER SCREW WAS REPLACED, CROSS LINK WAS PLACED. MULTI-SPAN WAS MANAGED TO BE PLACED, BUT FX WAS PLACED ON TH7/8. SET SCREW WAS TIGHTENED, BUT IT BECAME UNSTABLE DUE TO WHICH THE SURROUNDING BONE TISSUE WAS SCRAPPED AND CROSS-LINK DID NOT FIT. REVISION SURGERY WAS DONE AS THE CROSS-LINK DID NOT FIT AND EXCESSIVE RESECTION OF SURROUNDING BONE TISSUE WAS PERFORMED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-JUL-27: PLI40, PLI50, PLI60 AND PLI70 WERE ADDED AND REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854274 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G7643440 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention