BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 5655649 · Received May 16, 2016

    Report

    Report Number
    1030489-2016-01424
    Event Type
    Injury
    Date Received
    May 16, 2016
    Report Date
    May 2, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PRODUCTS WERE USED INCLUDING PRODUCT ID: 7540020, QTY: 2, 510K #: K052187. PRODUCT ID: 75446535, QTY: 3, 510K #: K042025. PRODUCT ID: 8690070, QTY: 1. 510K #: K010181. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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) 2006, THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF; POSTLAMINECTOMY INSTABILITY L4-5 <(>&<)> L5-S1. LOWER EXTREMITY RADICULOPATHY AND WEAKNESS. HERNIATED NUCLEUS PULPOSUS LUMBAR SPINAL STENOSIS L4-5 <(>&<)> L5-S1. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: REVISION LUMBAR LAMINECTOMIES WITH MEDIAL FACETECTOMIES AND FORAMINOTOMIES BILATERALLY FOR DECOMPRESSION OF DURA AND NEURAL ELEMENTS WITH USE OF OPERATING ROOM MICROSCOPE. TLIF USING STRYKER INTERBODY CAGE AT L4-5 <(>&<)> L5-S1. POSTERIOR SPINAL PEDICLE SCREW INSTRUMENTATION USING PEDICLE SCREW INSTRUMENTATION AT L4-5 <(>&<)> L5-S1. POSTEROLATERAL FUSION AT L4-5 <(>&<)> L5-S1. PER OP NOTES, "..BONE GRAFT WAS CAREFULLY PACKED ALONG THE ENTIRE ASPECT OF THE INTERSPACE AT L4-5 <(>&<)> L5-S1 ALONG THE ANTERIOR LONGITUDINAL LIGAMENT. DECORTICATION WAS COMPLETELY CARRIED OUT AND THE SOFT TISSUE WAS CAREFULLY REMOVED FROM THE AREA OF FUSION AND BONE GRAFT WAS CAREFULLY PACKED ALONG THIS AREA WITH EXCELLENT AMOUNT OF BONE GRAFT FOR THE POSTEROLATERAL FUSION ." ON (B)(6) 2007, THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF: LUMBAR FUSION , L4-5 <(>&<)> L5-S1. PAINFUL DEEP HARDWARE, L4-5 <(>&<)> L5-S1. INTERMITTENT RADICULOPATHY , L4-5 <(>&<)> L5-S1. THE PATIENT UNDERWENT FOLLOWING PROCEDURES; INSPECTION OF FUSION AT L4-5 <(>&<)> L5-S1. REMOVAL OF DEEP PAINFUL HARDWARE AT, L4-5 <(>&<)> L5-S1. PER OP-NOTES, " ..SET SCREWS , PEDICLE SCREWS AND RODS WERE REMOVED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312006 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R