BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 6986358 · Received October 30, 2017

    Report

    Report Number
    1030489-2017-02271
    Event Type
    Injury
    Date Received
    October 30, 2017
    Report Date
    October 30, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES LED TO THE EVENT, WE ARE FILLING THIS EVENT FOR NOTIFICATION PURPOSE. FOLLOWING DEVICES WERE INVOLVED. PRODUCT ID: 2961222, LOT NO: MW53, 510(K): K041556, UDI: (B)(4), QTY.: 1, PRODUCT CODE: MQP PRODUCT ID: 2961222, LOT NO: H07C2092, 510(K): K041556, UDI: (B)(4), QTY.: 1, PRODUCT CODE: MQP PRODUCT ID: 2961222, LOT NO: KP80, 510(K): K041556, UDI: (B)(4), QTY.: 1, PRODUCT CODE: MQP PRODUCT ID: 2961222, LOT NO: LW81, 510(K): K041556, UDI: (B)(4), QTY.: 1, PRODUCT CODE: MQP PRODUCT ID: 75447540, LOT NO: UNK, 510(K): K042025, UDI: (B)(4), QTY: 2, PRODUCT CODE: KWP PRODUCT ID: 8690080, LOT NO: UNK, 510(K): K010181, UDI: (B)(4), QTY: 2, PRODUCT CODE: KWP PRODUCT ID: 75446545, LOT NO: UNK, 510(K): K042025, UDI: (B)(4), QTY: 4, PRODUCT CODE: KWP PRODUCT ID: 7540020, LOT NO: UNK, 510(K): K052187, UDI: (B)(4), QTY: 6, PRODUCT CODE: KWP. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE SPONDYLOSIS L4-5, L5-S1 WITH CENTRAL STENOSIS AS WELL AS FORAMINAL STENOSIS, AND UNDERWENT THE FOLLOWING PROCEDURES: POSTEROLATERAL FUSION OF THE LUMBAR SPINE L4-5, L5-S1. POSTERIOR INTERBODY FUSION L4-5, L5-S1. APPLICATION OF INTERBODY DEVICE L4-5, L5-S1. POSTERIOR INSTRUMENTATION L4 TO S1. POSTERIOR LUMBAR DISCECTOMY L4-5, L5-S1. AUTOGRAFT FROM LAMINECTOMY, BILATERAL LATERAL FUSION. AS PER OP-NOTES, ¿AT THE LEVEL OF L4-5 A TRIAL OF SIZE 12X22 WAS PLACED IN C-ARM FLUOROSCOPY WAS USED TO CORRECTLY IDENTIFY THAT THIS WAS THE CORRECT SIZE. THIS TRIAL WAS LEFT IN THE LEFT SIDE. ON THE RIGHT SIDE, SIMILAR PROCEDURE, MOBILIZATION OF THE EPIDURAL VENOUS PLEXUS WITH THE BIPOLAR CAUTERY, FOLLOWED BY SERIAL REAMING WITH THE SYSTEM UP TO A SIZE 12. AT THIS POINT, END PLATE CUTTER WAS USED, FOLLOWED BY REMOVAL OF EXCESS TISSUE, FOLLOWED BY PLACEMENT OF A 12X22X2 PEEK CAGE WITH BMP SOAKED COLLAGEN SPONGE. ONCE THIS WAS IN POSITION, THE TRIAL WAS REMOVED FROM THE LEFT SIDE OF L4-5 AND SERIAL REAMED TO SIZE 12, FOLLOWED BY END PLATE SCRAPING, FOLLOWED BY PLACEMENT OF ANOTHER 12X22 MM PEEK CAGE WITH BMP COLLAGEN SOAKED SPONGES. STARTING POINT WAS BEGUN WITH THE STARTING AWL, FOLLOWED BY CANNULATION OF THE PEDICLE WITH THE PEDICLE FINDER, FOLLOWED BY MEASUREMENT, FOLLOWED BY PLACEMENT OF 6.5 X 45 SCREW IN THE RIGHT AND LEFT PEDICLES OF L5. IN ADDITION AT THE LEVEL OF L5, THE PEDICLE WAS PALPATED FROM WITHIN THE DECOMPRESSION REGION AND THIS ENSURED GOOD POSITION OF THE SCREW. WITH RESPECT TO THE S1 PEDICLES, THE INFERIOR ARTICULAR PROCESS WAS TAKEN DOWN WITH A CLOWARD OSTEOTOME. STARTING POINT WAS DONE WITH STARTING AWL, FOLLOWED BY FURTHER PALPATION, FOLLOWED BY MEASUREMENT, FOLLOWED BY PLACEMENT OF A 7.5 X 40 SCREW BILATERALLY IN THE S1 PEDICLES. AT THIS POINT, 8CM X 5.5 MM ROD WAS PLACED WITHIN THE POLYAXIAL HEADS AND CAPS WERE THEN PLACED ON AS WELL AND THE MIDDLE SCREWS WERE TORQUED DOWN SEPARATELY.¿ ON (B)(6) 2007: THE PATIENT WAS DISCHARGED FROM THE FACILITY. ON (B)(6) 2008: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH POSSIBLE PSEUDO ARTHROSIS AND PAINFUL HARDWARE L4-5, L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: POSTEROLATERAL FUSION L4-5 BILATERALLY, POSSIBLE L4-L5-S1. EXPLORATION OF FUSION L4-5, L5-S1. REMOVAL OF HARDWARE L4-5, L5-S1. PLACEMENT OF AUTOGRAFT BILATERALLY IN THE GUTTERS WITH AUTOGRAFT FROM THE FUSION MASS ALONG WITH BONE MORPHOGENIC PROTEIN AND GRAFT. CONTINUE NEUROPHYSIOLOGICAL MONITORING. AS PER OP-NOTES, ¿USING APPROPRIATE SCREWS, DRIVERS WERE USED TO FIRST REMOVE THE END CAPSULE, FOLLOWED BY REMOVAL OF THE CROSS LINK, FOLLOWED BY REMOVAL OF THE RODS, FINALLY BY REMOVAL OF THE SCREWS THEMSELVES. PRESSING UPON THE VERTEBRAL BODIES DID NOT RUN ON THE SPINOUS PROCESSES OR PEDICLES DID NOT DEMONSTRATE ANY MOTION. HOWEVER OUT LATERALLY, IT WAS NOTED THAT THERE MAY BE POSSIBLE PSEUDO ARTHROSIS AND GIVEN THIS, POSTEROLATERAL GRAFT WAS UNDERTAKEN FROM L4-5, LS-S1 BY PLACEMENT OF GRAFT ALONG WITH BONE MORPHOGENIC PROTEIN AFTER THIS AREA HAD BEEN APPROPRIATELY DECORTICATED. THE DECORTICATED BONE WHICH WAS PART OF THE FUSION MASS WAS PLACED OUT LATERALLY AS WELL IN ORDER TO AUGMENT THE FUSION.¿ ON (B)(6) 2008: THE PATIENT WAS DISCHARGED FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767531 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention