BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSLACE SPINAL TETHERING SYSTEM

    MDR report key: 10052243 · Received May 13, 2020

    Report

    Report Number
    1030489-2020-00521
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    April 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    OWI
    UDI-DI
    00763000108397
    PMA / PMN Number
    K163181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OWI: BONE FIXATION CERCLAGE, SUBLAMINAR. 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. 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 PRESENTED WITH SCOLIOSIS; AND UNDERWENT A CORRECTION SURGERY AT T6-L3. INTRA-OP, AFTER PLACEMENT WAS PERFORMED, THE TETHERS BROKE WHILE APPLYING TENSION WITH THE TENSIONER. TENSION WAS APPLIED WHEN CORRECTION WAS ONCE PERFORMED. AFTER PROVISIONAL FIXATION, LOOSENING WAS PERFORMED. AND WHEN TENSION WAS APPLIED AGAIN DURING THE SECOND CORRECTION, THE TETHERS BROKE. THEREFORE, PRODUCT FROM ANOTHER MANUFACTURER (NESPLON) WAS USED. THE SURGEON WONDERED WHETHER CORRECTION WAS PERFORMED EXCESSIVELY. THE BROKEN PRODUCT WAS REMOVED WITH NO FRAGMENT OF THE PRODUCT REMAINING INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516145 TRANSLACE SPINAL TETHERING SYSTEM OWI MEDTRONIC SOFAMOR DANEK USA, INC NA VS17C001 00763000108397

    Patients

    Seq Age Sex Outcome Treatment
    1