BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSLACE SPINAL TETHERING SYSTEM

    MDR report key: 9429319 · Received December 6, 2019

    Report

    Report Number
    1030489-2019-01387
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 5, 2019
    Report Date
    March 31, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE TETHER CABLES HAVE BEEN RETURNED TORN/SEPARATED IN SEVERAL DIFFERENT LOCATIONS. A VISUAL REVIEW OF THE FAILURE POINTS SHARES A CONSISTENT PHYSICAL APPEARANCE. THERE IS NECKING AROUND AND LEADING UP TO THE POINT OF SEPARATION. THIS TYPE OF DAMAGE IS CONSISTENT WITH A PULLING FORCE BEING APPLIED TO THE MATERIAL LEADING TO THE MATERIAL OVERLOAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 SPINAL FUSION, SAGITTAL RE-ALIGNMENT AND DEROTATION. INTRA-OP, DURING CURVE CORRECTION, WHILE TENSIONING THE TETHER, THE INSTRUMENT STARTED DAMAGING THE TISSUE OF THE TETHER; HENCE, THE PHYSICIAN HAD TO STOP APPLYING TENSION. THEN, THE DAMAGED DISTAL PART OF THE TETHER WAS CUT AND REMOVED. THE BROKEN PART DID NOT REMAIN INSIDE THE PATIENT. REPORTEDLY, A VERY GOOD CORRECTION OF THE SCOLIOTIC CURVE COULD NOT BE PERFORMED DUE TO THIS EVENT; HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226097 TRANSLACE SPINAL TETHERING SYSTEM OWI MEDTRONIC SOFAMOR DANEK USA, INC NA VS18C001 00763000108397

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR