BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 14203829 · Received April 26, 2022

    Report

    Report Number
    1030489-2022-00399
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 7, 2021
    Report Date
    April 26, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HWC
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. H6: 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 · 0

    AYMAN HUSSEIN , HAMDY IBRAHIM, HAZEM MASHALY, SAMEH HEFNY AND ABDELRAHMAN EL GAYAR. ASSESSMENT OF THE OUTCOME OF PERCUTANEOUS PEDICLE SCREWS IN MANAGEMENT OF DEGENERATIVE AND TRAUMATIC DORSAL AND LUMBAR PATHOLOGIES. THE EGYPTIAN JOURNAL OF NEUROLOGY, PSYCHIATRY AND NEUROSURGERY (2021) 57:50 HTTPS://DOI.ORG/10.1186/S41983-021-00305-4. THIS IS A PROSPECTIVE OBSERVATIONAL STUDY FROM JANUARY 2018 TO DECEMBER 2019 THAT INCLUDED 20 CONSECUTIVE PATIENTS WITH DEGENERATIVE AND TRAUMATIC DORSAL AND/OR LUMBAR SPINE PATHOLOGIES WHO WERE OPERATED FOR PERCUTANEOUS PEDICLE SCREWS FIXATION WITH OR WITHOUT INTERBODY CAGE FUSION. PATIENTS WERE FOLLOWED-UP FOR 12 MONTHS AFTER THE OPERATION. TWENTY PATIENTS WHO HAD DIFFERENT DORSAL OR LUMBAR DEGENERATIVE AND TRAUMATIC PATHOLOGIES WERE ENROLLED IN THE STUDY AS THEY DID NOT EXPERIENCE ADEQUATE RELIEVE OF THEIR SYMPTOMS WITH NONSURGICAL LINES OF MANAGEMENT. WEDGE FRACTURES, SPONDYLOLISTHESIS, AND DISC PROLAPSES WERE THE MOST COMMON INDICATIONS. NO WOUND DRAINS WERE NEEDED EXCEPT FOR CASES THAT NEEDED OPEN NEURAL DECOMPRESSION THROUGH CONVENTIONAL MIDLINE INCISION. NEITHER THERE WERE ACQUIRED NEUROLOGICAL OR VASCULAR DEFICITS IN THE POST-OPERATIVE STATE SECONDARY TO THE OPERATIVE PROCEDURE, NOR THERE WERE STRUCTURAL INSTABILITIES THAT REQUIRED A REVISION SURGERY DESPITE HAVING 7 SCREWS WITH MILD TO MODERATE MISPLACEMENT AND THE RADIOLOGICAL ASSESSMENT 6 MONTHS AFTER THE OPERATION REVEALED NO HARDWARE FAILURE. NO CASES REQUIRED BLOOD TRANSFUSION SECONDARY TO THE INTRA OR POST-OPERATIVE BLOOD LOSS. THERE WERE NO ENCOUNTERED SUPERFICIAL OR DEEP OPERATIVE SITE INFECTIONS AND NO CEREBROSPINAL FLUID LEAK OCCURRED AS THERE WERE NO CASES OF INTRAOPERATIVE UNINTENDED DUROTOMY. REPORTED EVENTS: THERE WAS A CASE OF A PERCUTANEOUS PEDICLE SCREW ANTERIOR BREACH OF THE BODY, THE PATIENT DID NOT SHOW ANY COMPLICATIONS SECONDARY TO THE ANTERIOR BREACH AND NO FURTHER INTERVENTION OR REVISION SURGERY WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044002 UNKNOWN HWC MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_SCREW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female