BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLYDESDALE SPINAL SYSTEM

    MDR report key: 20724495 · Received November 19, 2024

    Report

    Report Number
    1030489-2024-01531
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    May 24, 2024
    Report Date
    November 19, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION INCLUDING WEB ADDRESS/LITERATURE REFERENCE (DOI): HTTPS://DOI.ORG/10.3390/MEDICINA60060860. APPLY THE FOLLOWING STATEMENTS AS NECESSARY: B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. D4: PRODUCT IDENTIFIERS ARE UNKNOWN. G2: COUNTRY OF ORIGIN IS JAPAN. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING 'CAN WE RELY ON PROPHYLACTIC TWO-LEVEL VERTEBRAL CEMENT AUGMENTATION IN LONG-SEGMENT ADULT SPINAL DEFORMITY SURGERY TO REDUCE THE INCIDENCE OF PROXIMAL JUNCTIONAL COMPLICATIONS'. THE FOLLOWING MEDTRONIC DEVICES WERE USED: POLYETHER ETHER KETONE (PEEK) CAGES. AMONG PATIENTS' ADVERSE EVENTS/DEVICE PERFORMANCE ISSUES INCLUDED: AS EARLY AS 2 MONTHS POSTOPERATIVELY, DESPITE THE RELIEF OF PREOPERATIVE LOW-BACK PAIN, PATIENT HAD A NEUROLOGIC CATASTROPHE OF PARAPARESIS WITH DIFFICULTY RISING FROM THE CHAIR. THE PLAIN RADIOGRAPHS AND CT SCANS INDICATED NEITHER A PJA INCREASE NOR A VERTEBRAL FRACTURE NOR AN IMPLANT FAILURE BUT THE MRI SCANS SHOWED A DISTINCT SPINAL CORD COMPRESSION AT THE T9¿T10 INTERVERTEBRAL LEVEL . PATIENT NEEDED TO HAVE EMERGENCY SURGERY, EXTENDING THE POSTERIOR INSTRUMENTED FUSION PROXIMALLY TO T5 WITH SPINAL CORD DECOMPRESSION. THE PARAPARESIS GRADUALLY RESOLVED AND PATIENT BECAME AMBULATORY WITH A CANE AT THE 4-YEAR POSTOPERATIVE FOLLOW-UP. AS EARLY AS 6 MONTHS POSTOPERATIVELY, DESPITE THE RELIEF OF PREOPERATIVE LOW-BACK PAIN, PATENT HAD SPASTIC PARAPARESIS. THE PLAIN RADIOGRAPHS INDICATED PJK WITH SEGMENTAL INSTABILITY AT THE T9¿T10 LEVEL AND LATERAL MYELOGRAMS SHOWED A ¿BLOCK¿ TO THE FLOW OF INTRATHECAL CONTRAST AT T9¿T10 LEVEL WITH A T10 FRACTURE. THE CT SCAN AND T2 WEIGHTED MRIS MORE CLEARLY DEPICTED THE UIV FRACTURE WITHOUT THE SCREW PULLOUT AND A DISTINCT SPINAL CORD COMPRESSION AT THE T9¿T10 INTERVERTEBRAL LEVEL. PATIENT NEEDED TO HAVE EMERGENCY SURGERY, EXTENDING THE POSTERIOR INSTRUMENTED FUSION PROXIMALLY TO T5 WITH SPINAL CORD DECOMPRESSION. THE PARAPARESIS GRADUALLY RESOLVED AND HE BECAME AMBULATORY WITH A WALKING FRAME AT THE 3-YEAR POSTOPERATIVE FOLLOW-UP. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74340 CLYDESDALE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_CLYD_IMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention