BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 5499870 · Received March 15, 2016

    Report

    Report Number
    1030489-2016-00690
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 17, 2016
    Report Date
    June 7, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG NUMBER 2991226 AND 510K #K073291 IS APPROVED FOR SALE IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED PORTION OF THE IMPLANT IDENTIFIED WITNESS MARKS AND DEFORMATION ON THE TOP FACE OF THE IMPLANT AND THE BOTTOM THREAD FLANK ORIENTED APPROXIMATELY OPPOSITE TO THE FACE DEFORMATION ARE CONSISTENT WITH BENDING STRESS OVERLOAD DURING IMPACTION. THE FRACTURE SURFACE FOLLOWS THE ROOT OF THE THREAD TOOTH, AS INDICATED BY THE FRACTURE SURFACE MORPHOLOGY. A SHEAR LIP IS ALSO NOTED, CONSISTENT WITH OVERLOAD.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S1 DUE TO SPONDYLOLISTHESIS. INTRA-OP, DURING INSERTION A SMALL POSTERIOR PORTION OF THE CAGE BROKE AWAY WHICH REMAINED ATTACHED TO THE INSERTER. THE REMAINING PART OF THE CAGE REMAINED IMPLANTED. THE BROKEN OFF PORTION WAS A VERY THIN PORTION OF THE POSTERIOR END OF THE CAGE. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN.

    Description of Event or Problem · 1

    THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156346 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG 2991226INT H13J2025

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR