BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1030489-2021-00686

    MDR report key: 11869212 · Received May 24, 2021

    Report

    Report Number
    1030489-2021-00686
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    February 5, 2021
    Report Date
    May 24, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: MEAN AGE OF RR GROUP 14.1 ¿ 2.4 (RANGE 1019 YRS) <(>&<)> MEAN AGE OF ST2R GROUP 14.8 ¿ 2.1 (RANGE 1120 YRS) A3. SEX: 52 FEMALES (27 IN RR AND 25 IN ST2R GROUP). WEIGHT: MEAN WEIGHT OF RR GROUP 46.4 ¿ 4.6 (RANGE 33.054.7 KGS) & MEAN WEIGHT OF ST2R GROUP 45.3 ¿ 7.5 (RANGE 29.065.0 KGS) . PRODUCT CODE: KWP. COMMON DEVICE NAME: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY. COUNTRY: (B)(6). 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. ALTHOUGH IT IS UNKNOWN WHETHER THE MDT PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SAKAI D, ET AL. SIMULTANEOUS TRANSLATION ON TWO RODS IMPROVES THE CORRECTION AND APEX TRANSLOCATION IN ADOLESCENT PATIENTS WITH HYPO KYPHOTIC SCOLIOSIS. J NEUROSURG SPINE 34:597607, 2021. SUMMARY: RESOLVING HYPO-KYPHOTIC AIS REMAINS CHALLENGING. THE ST2R TECHNIQUE SUPPORTED SIGNIFICANT TRIPLANAR CORRECTIONS, INCLUDING TK APEX TRANSLOCATION AND RESTORATION OF HYPOKYPHOSIS IN MOST PATIENTS. COMPARISONS WITH THE RR COHORT REQUIRE CAUTION BECAUSE OF DIFFERENCES IN THE IMPLANT PROFILE. HOWEVER, ST2R SIGNIFICANTLY IMPROVED THE CORONAL AND SAGITTAL CORRECTIONS. IT ALSO ALLOWED FOR DISTRIBUTION OF CORRECTIONAL FORCES OVER TWO ROD IMPLANTS INSTEAD OF ONE, WHICH SHOULD DECREASE THE RISK OF SCREW PULLOUT AND ROD FLATTENING. IT IS HOPED THAT THE DESCRIPTION HERE OF COMMERCIALLY AVAILABLE REDUCERS USED WITH THE AUTHORS SURGICAL TECHNIQUE WILL ENCOURAGE OTHER CLINICIANS TO CONSIDER USING THE ST2R TECHNIQUE. INFORMED CONSENT WAS OBTAINED FROM THE PATIENTS INCLUDED OR WAS COLLECTED FROM A PARENT OR LEGAL GUARDIAN OF PARTICIPANTS YOUNGER THAN 18 YEARS. IN TOTAL, 52 FEMALE PATIENTS WITH AIS WITH A TK <(><<)> 20¿ WERE INCLUDED. SPECIFICALLY, THIS INVOLVED AN ST2R COHORT, WHICH INCLUDED 25 PATIENTS SUBJECTED TO ST2R, TREATED FROM APRIL 2014 TO DECEMBER 2017, AND A HISTORICAL CONTROL GROUP WITH 27 SUBJECTS TREATED BY RR FROM JANUARY 2011 UNTIL APRIL 2014. THE AVERAGE PATIENT AGES WERE 14.1 ¿ 2.4 AND 14.8 ¿ 2.1 YEARS FOR THE RR AND ST2R COHORTS, RESPECTIVELY. PATIENTS WERE CASE MATCHED AND SELECTED ACCORDING TO THE MAIN COBB ANGLE IN THE THORACIC REGION T212 AND WERE MAINLY CLASSIFIED AS LENKE TYPE 1. UPON CONFIRMATION, COMMERCIALLY AVAILABLE REDUCERS (E.G., ROCKETS THREADED REDUCERS, ZIMMER BIOMET; DEFORMITY CRICKETS, K2M, INC.; OR SMARTLINK, MEDTRONIC) WERE ATTACHED ONTO THE PEDICLE SCREWHEADS. REPORTED EVENTS: ALL SURGICAL PROCEDURES WERE PERFORMED SUCCESSFULLY WITHOUT ANY MAJOR PERIOPERATIVE COMPLICATIONS, I.E., NO INSTRUMENTATION FAILURE OR OTHER SURGICAL COMPLICATIONS RECORDED. INTRAOPERATIVE MONITORING REVEALED NO EPISODES OF CHANGE TO INDICATE MAJOR NEUROLOGICAL DEFICITS OR OTHER COMPLICATIONS. NEITHER COHORT REPORTED ANY NON-FUSION CASES. 1. A MINOR WOUND INFECTION WAS RECORDED IN THE ST2R COHORT, WHICH RESOLVED AFTER AN ANTIBIOTIC REGIMEN. 2. ONE WOUND INFECTION WAS RECORDED IN THE RR GROUP, WHICH WAS SUCCESSFULLY RESOLVED BY WOUND DEBRIDEMENT AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769004 KWP MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_HARDWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention