BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON

    MDR report key: 12194529 · Received July 20, 2021

    Report

    Report Number
    1030489-2021-00951
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Report Date
    July 20, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 75445540 AND 510K# K042025 IS APPROVED FOR SALE IN US. ADVERSE EVENT OR PRODUCT PROBLEM: G75445540 IS NOT MARKETED IN THE US, BUT IS SIMILAR TO OTHER MARKETED DEVICES. THUS, IT IS REPORTABLE FOR MALFUNCTION, NOT SERIOUS INJURY, ALTHOUGH SURGICAL INTERVENTION DID TAKE PLACE. 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. IT IS UNKNOWN WHICH OF THE BELOW PRODUCT WAS LOOSENED AND CAUSED SURGICAL INTERVENTION IN THE PATIENT. PART# G75445540; LOT# H5475165; QTY# 1. PART# G75446540; LOT# H5278025; QTY# 1. PART# G75446540; LOT # H5441242; QTY# 1. PART# G75446540; LOT# H5505642; QTY# 1. PART# G75446545; LOT# H5336363; QTY# 2. PART# G75446545; LOT# H5427623; QTY# 1. PART# G75446545; LOT# H5429194; QTY# 2. PART# G75446545; LOT# H5500409; QTY# 1. PART# G75447545; LOT# H5517991; QTY# 4. PART# G869H021; LOT# 0685129W; QTY# 1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH COLLAPSE OF T12 INVOLVED IN POSTERIOR FUSION PROCEDURE OF T12-S1. LEVELS IMPLANTED: T8-S2AI. IT WAS REPORTED THAT DURING USE, DUE TO THE COLLAPSE OF T12 AND THE LOOSENING OF THE SCREW OF S1, REVISION SURGERY WAS PERFORMED. PATIENT SYMPTOMS PAIN WAS REPORTED. IN REVISION SURGERY ALL PRODUCTS WERE REMOVED, AND SCREWS WERE INSERTED AT T8, 9, 10, 11, L1, 3, 5, S1 AND S2AI, AND PLIF WAS PERFORMED AT L5-S1. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WAS NO PRODUCT MALFUNCTION OCCURRED. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. PATIENT OUTCOME: THERE WAS HEALTH DAMAGE ON THE PATIENT. ON 2021-JULY-05, RECEIVED ADDITIONAL INFORMATION THAT REASON FOR REMOVAL OF SCREW WAS COLLAPSE OF T12, S1 SCREW LOOSENESS AND REPLACEMENT FROM LEGACY TO SOLERA. PRODUCT WAS IMPLANTED AT T12, BUT IT WAS DISCARDED. SCREW: 14 PIECES, ROD: ONE PIECE WERE REMOVED IN THE REVISION SURGERY. INITIAL SURGERY: POSTERIOR FUSION OF T12-S1 WAS PERFORMED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095197 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G75445540 H5475165

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention