BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE UNKNOWN PRODUCT

    MDR report key: 9232803 · Received October 24, 2019

    Report

    Report Number
    2210968-2019-89014
    Event Type
    Injury
    Date Received
    October 24, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED (15 YEAR-OLD FEMALES, N=2) IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (PDS PLATE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PDS PLATE) USED IN THIS PROCEDURE? CITATION: INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY 111 (2018) 97-102. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE : FUNCTIONAL SEPTORHINOPLASTY IN THE PEDIATRIC AND ADOLESCENT PATIENT". AUTHORS : JENNIFER C. FULLERA,B,*, PATRICIA A. LEVESQUEA,B, ROBIN W. LINDSAYA, JENNIFER C. FULLERA,B,*, PATRICIA A. LEVESQUEA,B, ROBIN W. LINDSAYA, CITATION: INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY 111 (2018) 97-102. THIS SINGLE-CENTER PROSPECTIVE OBSERVATIONAL STUDY AIMED TO DESCRIBE PEDIATRIC AND ADOLESCENT PATIENTS UNDERGOING FUNCTIONAL SEPTORHINOPLASTY AND TO ANALYZE BOTH SUBJECTIVE AND OBJECTIVE OUTCOMES. BETWEEN 2013-2017, A TOTAL OF 39 PATIENTS (N=19 MALE, N=20 FEMALE; MEAN AGE OF 15.9 YEARS, AGE RANGE OF 7-18) WITH NASAL OBSTRUCTION WERE INCLUDED IN THE STUDY. OUT OF 39 PATIENTS, PDS PLATE WAS USED BY 11 PATIENTS DURING THE FUNCTIONAL SEPTORHINOPLASTY. COMPLAINT INCLUDED 15-YEAR-OLD FEMALES (N=2) WHO UNDERWENT REVISION SURGERY DUE TO RECURRENT SEPTAL DEVIATION. IN THE FIRST CASE, THE RECURRENCE DEVELOPED AT 15 MONTHS POST-OPERATIVELY AND SHE UNDERWENT AN OPEN SEPTORHINOPLASTY WITH SEPTAL CARTILAGE SPREADER, COLUMELLAR STRUT, AND ALAR RIM GRAFT PLACEMENT. IN THE SECOND CASE, THE PATIENT HAD SEVERE INTERNAL NASAL VALVE NARROWING AND THE REVISION SURGERY AT 15 MONTHS INVOLVED OPEN SEPTORHINOPLASTY, REMOVAL OF ADDITIONAL SEPTAL CARTILAGE, SWINGING DOOR TECHNIQUE, AND ALAR RIM GRAFTS, AND NASAL BONE OSTEOTOMIES. FUNCTIONAL SEPTORHINOPLASTY IS SAFE AND EFFECTIVE IN SELECT PEDIATRIC AND ADOLESCENT PATIENTS WITH SIGNIFICANT NASAL OBSTRUCTION AND RESULTS IN SIGNIFICANT IMPROVEMENTS IN BOTH SUBJECTIVE AND OBJECTIVE OUTCOMES MEASURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027850 PDS PLATE UNKNOWN PRODUCT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention