BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 6753244 · Received July 31, 2017

    Report

    Report Number
    1030489-2017-01829
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    July 3, 2017
    Report Date
    September 28, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 2990826, 510K# K073291 AND (B)(4) IS APPROVED FOR THE US MARKET. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A ~3MM PORTION OF THE TOP FACE OF THE IMPLANT, WHICH INTERFACES DIRECTLY WITH THE INSERTER. OPTICAL AND MICROSCOPIC EXAMINATION OF THE RETURNED PORTION OF THE IMPLANT IDENTIFIED A BRITTLE FRACTURE WITH RAYS EMANATING FROM THE ROOT OF THE THREAD TOOTH. ADDITIONALLY, THE CORNER OF THE INSERTER INTERFACE IS FRACTURED WITH AN ANGULATED CRACK, CONSISTENT WITH A TORSIONAL COMPONENT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH SIGNIFICANT FORCE DURING ATTEMPTED IMPLANTATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: SPONDYLOLISTHESIS L5-S1 PROCEDURE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION- MAST IT WAS REPORTED THAT DURING SURGERY THE DEVICE BROKE WHILE POSITIONING. MOST OF THE IMPLANT COULD NOT BE EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533749 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5182702

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR