BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYOPLANT 4X5CM

    MDR report key: 10656060 · Received October 9, 2020

    Report

    Report Number
    9610612-2020-00684
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    August 27, 2020
    Report Date
    October 29, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    GXQ
    PMA / PMN Number
    K970851
    Removal / Correction Number
    0301030000-2020-8007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WITH REFERENCE TO THE FDA-LETTER OF (B)(6) 2020 WITH FDA REPORT NUMBER 0301030000-2020-8007 WE SUBMIT THE FOLLOWING COMMENTS. 1. PLEASE CONFIRM OR PROVIDE THE MODEL, LOT, SERIAL, AND/OR CATALOG NUMBER(S) OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT AS APPLICABLE. - INFORMATION ALREADY SUBMITTED IN THE INITIAL MDR REPORT OF (B)(6) 2020. 2. WHAT QUALITY CONTROL PROCEDURES AND TESTING DOES YOUR FIRM EMPLOY TO ENSURE OUTGOING PRODUCT MEETS DESIGN AND PERFORMANCE SPECIFICATIONS? DESCRIBE ACCEPTANCE AND REJECTION CRITERIA AND SPECIFY SAMPLING PROCEDURES. - DURING MANUFACTURING VARIOUS IN-PROCESS CONTROLS (LINEAR TEARING FORCE, CHEMICAL TEST, ETC.) ARE CARRIED OUT. THE FINAL INSPECTION OF THIS ARTICLE WAS CARRIED OUT AND IS IN CONFORMANCE WITHOUT ANY DEVIATIONS OF THE FINAL PRODUCT SPECIFICATIONS. FOR FINAL INSPECTION A DESTRUCTIVE RANDOM INSPECTION OF A PART OF EVERY BATCH IS CARRIED OUT. THE BATCH REJECTION CRITERIA IS DEFINED WITH A ZERO-ERROR LIMIT. THERE IS NO SPECIAL RELEASE PROCEDURE ACCEPTABLE FOR THIS DEVICE. 3. PLEASE PROVIDE A MORE COMPLETE DESCRIPTION OF THIS EVENT INCLUDING ANY RELEVANT DETAILS SURROUNDING THE EVENT - AVAILABLE INFORMATION ALREADY SUBMITTED IN THE INITIAL MDR REPORT OF OCTOBER 9,2020. 4. PLEASE PROVIDE ANY EVALUATION OF THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT BY THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL. - ACCORDING TO OUR INITIAL 21 CFR 803 REPORTING EVALUATION, THIS EVENT IS DEEMED REPORTABLE FOR THE FOLLOWING REASON: ADVERSE EVENT DUE TO THE NECESSITY OF A REVISION SURGERY. 5. PLEASE PROVIDE THE RESULTS FOR ANY INVESTIGATION, EVALUATION, AND/OR FAILURE ANALYSIS, INCLUDING UNDERLYING CAUSE IDENTIFICATION, RELEVANT TO THE REPORTED EVENT. PLEASE INCLUDE: (1) AN EXPLANATION FOR THE REASON FOR THIS OCCURRENCE BASED ON YOUR FOLLOW-UP WITH THE REPORTING FACILITY OR INDIVIDUAL (2) A COMPLETE DESCRIPTION OF INVESTIGATION AND ANALYSIS METHODOLOGY(IES) USED, (3) AN IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED, AND (4) ANY CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS. - TO DATE THERE IS NO DEVICE AVAILABLE FOR INVESTIGATION. THEREFORE A INVESTIGATION OF THE DEVICE ITSELF WAS NOT POSSIBLE. DUE TO THE LACK OF INFORMATION SURROUNDING THE REPORTED CASE AND WITHOUT THE COMPLAINT SAMPLE BEING AVAILABLE FOR INVESTIGATION, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO INDICATION FOR A MATERIAL DEFECT, MANUFACTURING FAILURE OR DESIGN ERROR ON THE BASIS OF THE DEVICE HISTORY RECORD. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED TO US FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. 6. PLEASE PROVIDE ANY EVALUATION OF OTHER INFORMATION USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. - FROM THE EVALUATION OF THE DHR FILES THERE IS NO EVIDENCE AVAILABLE THAT THE REPORTED EVENT IS ATTRIBUTABLE TO THE DEVICE. 7. PLEASE DESCRIBE ALL STEPS IN THE MANUFACTURING PROCESS THAT COULD CONTRIBUTE TO THIS REPORTED PROBLEM, AND HOW YOU CONSIDERED THIS IN THE CONTEXT OF EVALUATING AND INVESTIGATING THIS DEVICE EVENT. - THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. 8. PLEASE PROVIDE A COMPLETE LIST OF MEDICAL DEVICE REPORTS (MDRS) THAT YOU HAVE DETERMINED ARE RELATED TO THIS SAME PROBLEM/ISSUE. PLEASE IDENTIFY HOW MANY COMPLAINTS (I.E. FROM ALL SOURCES, INCLUDING BUT NOT LIMITED TO FIELD SERVICE RECORDS, REPAIR HISTORY RECORDS, ETC.) THAT YOUR FIRM HAS RECEIVED IN THE PAST 2 YEARS THAT ARE RELATED TO THIS SAME REPORTED DEVICE PROBLEM. - THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER WITH THIS ERROR PATTERN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: THE CURRENT PATIENT STATUS IS STABLE POSTOPERATIVELY, AND IT WAS CONFIRMED THAT THE ONLY INTERVENTION REQUIRED WAS THE READMISSION FOR CSF LEAK; AND SURGERY OCCURRED TO REPAIR AND PATCH (WITH PATIENTS OWN TISSUE). SUTURING OF THE ORIGINAL LYOPLANT DURAL GRAFT WAS PERFORMED WITH 5-0 PROLENE SUTURE. THE OPERATIVE REPORT AND MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME AND THERE WERE NO PICTURES OR X-RAYS TAKEN.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT LYOPLANT 4X5CM AS PER INFORMATION PROVIDED VIA USER FACILITY REPORT NUMBER (B)(4). ACCORDING TO THE FACILITY REPORT (B)(4) A CSF LEAGING OCCURED 13 DAYS POST SURGERY. THE PATIENT HAD A CRANIECTOMY WITH A CLOSURE OF THE DURA UTILIZING A AESCULAP AG LYOPLANT (MODEL/CATALOG # 1066064, LOT # 220125) DURAL GRAFT ON [DATE REDACTED]. THE PATIENT RETURNED TO SURGERY 13 DAYS LATER FOR A REPAIR OF A CSF LEAK. DURING THIS SURGERY, THE SURGEON IDENTIFIED THAT THE DURAL GRAFT HAD "DISAPPEARED". THERE WERE NO SIGNS OF INFECTION OF THE SURGICAL SITE. THE CAUSE OF THE GRAFT FAILURE IS UNKNOWN. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121030 LYOPLANT 4X5CM DURA REPLACEMENT GXQ AESCULAP AG 1066064 220125

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention