BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2112874 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00667
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVERAGE AGE OF THE STUDY PATIENTS WAS (B)(6); AGES RANGED FROM (B)(6) YEARS POSTERIOR INSTRUMENTATION INCLUDING MPA SCREWS (DETAILS NOT PROVIDED). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. MULTIPLE PRODUCTS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    POST-OPERATIVE COMPLICATIONS WERE REPORTED IN A RETROSPECTIVE REVIEW OF PROSPECTIVE DATA FROM A DEFORMITY DATABASE OF 487 CONSECUTIVE SURGICAL PATIENTS TREATED WITH DIRECT INCREMENTAL SEGMENTAL TRANSLATION (DIST). ALL OF THE PATIENTS UNDERWENT POSTERIOR FUSION AND INSTRUMENTED DEFORMITY CORRECTION (EXCEPT GRADE 1 SP) WITH DIST USING UNIVERSAL STEPS. RELEASING THE SPINE TO MOVE OCCASIONALLY REQUIRED 3-COLUMN OSTEOTOMY (N=24), ANTERIOR RELEASE (N=113, AVERAGE 4.8 LEVELS) AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (N=294, AVERAGE 1.7 LEVELS). AT 5 YEARS FOLLOW UP (RANGE 24-108 MONTHS) NONUNION HAD BEEN REPORTED IN SEVENTEEN PATIENTS. IT IS UNCLEAR WHETHER REVISION SURGERY WAS REQUIRED OR NOT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention