BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 5362502 · Received January 13, 2016

    Report

    Report Number
    1030489-2016-00151
    Event Type
    Injury
    Date Received
    January 13, 2016
    Report Date
    December 16, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS WITH MULTIPLE LOT NUMBERS WERE USED IN THE EVENT. IT IS UNKNOWN WHICH PRODUCT CAUSED THE EVENT. 2990722 (QUANTITY-1), LOT NUMBER- H13A6183 2990722 (QUANTITY-1), LOT NUMBER- H13A5318. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PLIF SURGERY AT L5-S1. POSTOPERATIVE INFECTION WAS OBSERVED ON UNKNOWN DATE. REVISION SURGERY WAS SCHEDULED TO REMOVE CAGE. ACCORDING TO THE AGENT, INFECTION WAS OBSERVED AROUND THE CAGE, BUT NOT AROUND THE SCREW. THE SCREW AND IMPLANT WERE ALL REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21206 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Other| R