BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 6036116 · Received October 18, 2016

    Report

    Report Number
    2520274-2016-14882
    Event Type
    Injury
    Date Received
    October 18, 2016
    Report Date
    October 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: DUNN, R.N., BOMELA, L.N. (2016) KYPHECTOMY IN CHILDREN WITH SEVERE MYELOMENINGOCELE-RELATED KYPHOSIS. SPINE DEFORMITY, VOLUME 4, PP. 230-236. PRODUCT CODE: NKB. THIS INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE : DUNN, R.N., BOMELA, L.N. (2016) KYPHECTOMY IN CHILDREN WITH SEVERE MYELOMENINGOCELE-RELATED KYPHOSIS. SPINE DEFORMITY, VOLUME 4, PP. 230-236. THE PURPOSE OF THE STUDY WAS TO REVIEW MYELOMENINGEOCELE PATIENTS WITH SEVERE KYPHOSIS UNDERGOING KYPHECTOMY SURGERY IN TERMS OF COMPLICATIONS AND CLINICAL AND RADIOGRAPHIC OUTCOMES. BETWEEN SEPTEMBER 2004 AND 2014, SEVEN PATIENTS (3 FEMALES, 4 MALES) WITH AN AVERAGE AGE OF 9.5 YEARS (RANGE, 8-13) UNDERWENT KYPHECTOMY SURGERY TO REPAIR SEVERE KYPHOTIC DEFORMITY. PATIENTS WERE IMPLANTED WITH SYNTHES UNIVERSAL SPINE SYSTEM 1 (USS) TITANIUM SCREWS AT A MINIMUM OF THREE LEVELS BILATERALLY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS; HOWEVER, THE FOLLOWING POSTOPERATIVE COMPLICATIONS WERE REPORTED: TWO PATIENTS WITH PREOPERATIVE PRESSURE SORES PRESENTED WITH RECURRENT PERI-IMPLANT SEPSIS; ONE PATIENT DEVELOPED SKIN BREAKDOWN OVER THE ILIAC CREST INSTRUMENTATION AND A SCREW HEAD WAS VISIBLE THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN USS 1 TITANIUM SCREWS AND REFERS TO RECURRENT PERI-IMPLANT SEPSIS AND SKIN BREAKDOWN OVER ILIAC CRES INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689452 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention