BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SYSTEM

    MDR report key: 7272643 · Received February 15, 2018

    Report

    Report Number
    1030489-2018-00229
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 25, 2018
    Report Date
    May 28, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WITH THE FOLLOWING LOT# WERE USED IN THE SURGERY- LOT#: H12C4076, QTY: 1, AND LOT#: H5364603, QTY: 1. THE EVENT DESCRIBED DIDN¿T HAPPEN ON BOTH IMPLANTS BUT JUST ONE OF THE TWO. IT¿S NOT KNOWN WHICH ONE OF THE TWO PRODUCTS BROKE. WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSE. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2991432, 510K #K073291, UDI# (B)(4) WAS APPROVED FOR SALE IN THE UNITED STATES. 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 (LOT NUMBER OF THE PRODUCT COULD NOT BE IDENTIFIED): A VERY SMALL PORTION OF THE CAGE WAS RETURNED. THIS PIECE WAS THE BACKSIDE OF THE CAGE THAT CONNECTS TO THE INSERTER. THE THREADS APPEAR TO BE DAMAGED. A MICROSCOPIC REVIEW OF THE FRACTURE FACE IS CONSISTENT WITH MATERIAL OVERLOAD. DUE TO THE SMALL PORTION OF THE PRODUCT THAT WAS RETURNED NO TRUE ROOT CAUSE CAN BE IDENTIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTER-BODY FUSION (PLIF) AT L5-S1 DUE TO SPONDYLOLISTHESIS AT THAT LEVEL. DURING THE SURGERY, JUST A SMALL PIECE OF THE IMPLANT BROKE AFTER INSERTION. THE PART OF THE CAGE THAT BROKE WAS EXPLANTED. REST OF THE IMPLANT WAS VISIBLY INTACT AND NOT REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118228 CAPSTONE SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR