BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1030489-2016-01433

    MDR report key: 5656397 · Received May 16, 2016

    Report

    Report Number
    1030489-2016-01433
    Event Type
    Injury
    Date Received
    May 16, 2016
    Report Date
    April 25, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED INCLUDING: PRODUCT ID: 6190075, LOT NO.: UNK, QTY: 1; 6241041, 61BJ, 1; 6240141, ZJ80, 1,;5030841, YY24, 1; 5030741, 21AC, 1; G6626525, H5172419, 1. ALTHOUGH IT IS UNKNOWN WHETHER ANY OF THESE DEVICES CONTRIBUTED TO REPORTED EVENT WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES ONLY. (B)(4). NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION.

    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) 2016: PATIENT PRESENTED WITH NEUROMUSCULAR DISEASE, HEADACHES, ANXIETY AND IRRITABLE BOWEL. PATIENT UNDERWENT SURGERY WITH PRE-OPERATIVE DIAGNOSIS OF RECURRENT CERVICAL STENOSIS WITH MYELOPATHY. OPERATIVE PROCEDURE: C3-4, C4-5, C6-7 ANTERIOR CERVICAL DISCECTOMY. C5 CORPECTOMY, C3-7 ANTERIOR CERVICAL FUSION USING ANTERIOR PLATE SYSTEM, ABDOMINAL FAT GROWTH HARVEST. NEUROPXX HYSIOLOGICAL MONITORING WAS USED DURING THE ENTIRE PROCEDURE. AS PER OP NOTES: RDX WAS PLACED AT THE C-6-7 AND C3-4 LEVELS FOLLOWING DECOMPRESSION, PEEK CAGE WAS THE INSERTED IN TO C5 CORPECTOMY AND NOTED THAT THE CAGE FIT WELL. AT C6-C7 ANOTHER CAGE WAS PLACED IN TO THE DISCECTOMY CAVITY FOR ARTHRODESIS PURPOSES. C3-C4 CAGE WAS PLACED. FUSION PLATE (4 LEVELS) WAS THEN AFFIXED TO THE C3-4-6 AND 7 VERTEBRAL BODIES USING A TOTAL OF 8 SCREWS. FINAL FLUOROSCOPIC IMAGES REVEALED ALL INSTRUMENTATION TO BE IN APPROPRIATE POSITION. PATIENT WAS TAKEN TO THE RECOVERY IN STABLE CONDITION. PATIENT ALSO UNDERWENT X-RAY OF CERVICAL SPINE DUE TO STENOSIS. IMPRESSION: MULTILEVEL ACDF C3-C6, ANTERIOR STABILIZATION HARDWARE SPANS THESE LEVELS. THERE IS ADDITIONAL POSTERIOR STABILIZATION HARDWARE AND POSTERIOR DE-COMPRESSIVE POSTERIOR LAMINECTOMY C3 THROUGH C5. ON (B)(6) 2016: PATIENT X-RAY REVEALED EVIDENCE OF BREAKAGE OF PLATE AT THE SUPERIOR C6 LEVEL. IMPRESSION: THERE IS AN ANTERIOR FIXATION PLATE EXTENDING FROM C3 DOWN TO THE C7 LEVEL. THE FIXATION PLATES BECOME DISCONNECTED AT THE C5-6 LEVEL; WHICH IS NEW WHEN COMPARED TO THE INTRAOPERATIVE FLUOROSCOPIC IMAGE OF THE CERVICAL SPINE FROM (B)(6) 2016. THERE HAS BEEN ANTERIOR DISCECTOMY AND FUSION OF THE CERVICAL SPINE FROM C3-4 THROUGH C6-7. THE INTER BODY CAGE DEVICE ARE IN STABLE POSITION. POSTOPERATIVE CHANGES FROM PREVIOUS LAMINECTOMY AND POSTERIOR FIXATION OF THE SPINE FROM C3 THROUGH C5 ARE STABLE. THE POSTERIOR FIXATION HARDWARE IS INTACT. THE FINDINGS WERE DISCUSSED WITH THE SURGEON. ON (B)(6) 2016: PATIENT PRESENTED WITH NEUROMUSCULAR DISEASE, HEADACHES, ANXIETY. PATIENT UNDERWENT ANOTHER SURGERY FOR THE BROKEN FIXATION DEVICE TO BE REPLACED WITH PRE-OP DIAGNOSIS OF BROKEN PLATE. PROCEDURE PERFORMED REPLACEMENT OF ACDF PLATE. PLATE AND 8 SCREWS WERE REMOVED IN 2 PIECES AND WAS INSPECTED. THERE WAS AN OBVIOUS BREAK AT THE POINT NOTED ON X-RAY BEFORE. NO IMMEDIATE COMPLICATIONS NOTED. PATIENT UNDERWENT CERVICAL SPINE X-RAY. IMPRESSION: THERE HAS BEEN ANTERIOR DISCECTOMY AND FUSION OF THE CERVICAL SPINE FROM C3-4 THROUGH C6-7 AS WELL AS LAMINECTOMY AND POSTERIOR FIXATION AT C3 THROUGH C5. THE ANTERIOR PLATE EXTENDING FROM C3 THROUGH C7 HAS BEEN RECONNECTED AND NOW IS IN INTACT AND IN GOOD POSITION. THE REMAINDER OF THE HARDWARE IS INTACT AND IN IS IN GOOD POSITION. ON (B)(6) 2016: PATIENT PRESENTED DUE TO COMPLAINT OF SHARP CHEST PAIN AND COMPLAINS OF APPROPRIATE INCISION PAIN. X-RAY REVEALED SATISFACTORY POSTOP APPEARANCE. ON (B)(6) 2016: PATIENT PRESENTED WITH MUSCULOSKELETAL IMPAIRMENT, NEUROLOGIC IMPAIRMENT, PAIN. ON (B)(6) 2016: PATIENT WAS DISCHARGED. ON (B)(6) 2016: PATIENT UNDERWENT X-RAY OF ESOPHAGUS DUE TO DYSPHAGIA WITH RECENT CERVICAL FUSION. IMPRESSION: STATUS POST ANTERIOR PLATE AND SCREW FIXATION AND DISCECTOMY AT C3-7 WITH LAMINECTOMY POSTERIOR ROD AND SCREW FIXATION AT C4-C5. LIKELY POST SURGICAL SMOOTH PRE-VERTEBRAL SOFT TISSUE SWELLING IS PRESENT. PATIENT HAD CERVICAL PAIN, NECK-PAIN AND DIFFICULTY SWALLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313006 KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other