BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 7923604 · Received October 1, 2018

    Report

    Report Number
    1526439-2018-50932
    Event Type
    Injury
    Date Received
    October 1, 2018
    Report Date
    September 4, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    UDI-DI
    (01)UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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: 4,5 YEAR INFECTION RATE IN OPEN SPONDYLODESIS WITH DECOMPRESSION VERSUS THE LESS INVASIVE LIS TECHNIQUE IN LUMBAR SPINE AUTHORS: PFANDLSTEINER T., WIMMER C. SOURCE: EUROPEAN SPINE JOURNAL. 2010 NOV; CONFERENCE: 5TH GERMAN SPINE CONFERENCE- ANNUAL MEETING OF THE GERMAN SPINE SOCIETY. BREMEN GERMANY. CONFERENCE PUBLICATION: (VAR.PAGINGS). 19 (11) :1978. 1. DEEP INFECTION (AE ONLY ¿ EXPEDIUM SYSTEM) - UNKNOWN PATIENTS WITH OPEN MONO STABILIZATIONS, BI STABILIZATIONS, POLY-SEGMENTAL STABILIZATIONS AND OPEN STABILIZATION (2006-2010); DEEP INFECTION WAS EVALUATED. IN ALL DEEP INFECTIONS WIDE DEBRIDEMENT, JET LAVAGE, DRAINAGE WAS DONE, PARENTERAL ANTIBIOTICS 7 TO 10 DAYS BY ANTIBIOGRAM AND AFTERWARDS ORAL ANTIBIOTICS WERE GIVEN. IN DEEP INFECTIONS IN 3 CASES S. AUREUS, IN 4 CASES MRSE, IN 2 CASE E. COLI AND IN 1 CASE MRSA WAS FOUND. 2. PATIENT WITH DEEP INFECTION NEEDING REVISION (AE ONLY ¿ EXPEDIUM SYSTEM) - IN 1 UNKNOWN PATIENT WITH STAPHYLOCOCCUS AUREUS INFECTION, A 2ND REVISION WITH DEBRIDEMENT, JETLAVAGE, SURGICAL SITE DRAINAGE AND ANTIBIOTICS FOR 4 MONTHS WAS DONE. 3. SUPERFICIAL INFECTION (AE ONLY ¿ EXPEDIUM SYSTEM) - UNKNOWN PATIENTS WITH OPEN MONO STABILIZATIONS, BI STABILIZATIONS, POLY-SEGMENTAL STABILIZATIONS AND OPEN STABILIZATION (2006-2010); SUPERFICIAL INFECTION WAS EVALUATED. IN SUPERFICIAL INFECTIONS AFTER REVISION PARENTERAL ANTIBIOTICS OVER 3 DAYS, THEN ORAL ANTIBIOTICS DEPENDING ON THE ANTIBIOGRAM WERE GIVEN. IN SUPERFICIAL INFECTIONS IN 3 CASES S.AUREUS, IN 1 CASE E. COLI AND IN 2 CASES MRSE WAS FOUND. 4. DEVICE MALFUNCTION (MALFUNCTION ONLY ¿ EXPEDIUM SCREWS) ¿ SCREW LOOSENING - IN UNKNOWN PATIENTS WITH OPEN STABILIZATIONS; SCREW LOOSENING WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763169 UNKNOWN SCREWS UNKNOWN HWC MEDOS INTERNATIONAL SàRL CH (01)UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention