BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECTUS SYSTEM ELONGATED PECTUS STABILIZER

    MDR report key: 10462587 · Received August 27, 2020

    Report

    Report Number
    0001032347-2020-00398
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    August 12, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036011093
    PMA / PMN Number
    K981789
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED BECAUSE IT WAS REPORTED ADDITIONAL TREATMENT WAS PROVIDED TO RESOLVE THE ISSUE. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO PHOTOS, SCANS, X-RAYS, OR PHYSICIAN'S REPORTS WERE PROVIDED. FOR THESE REASONS, NO FUNCTIONAL TESTING OR INSPECTIONS COULD BE PERFORMED. THE DHR WAS REVIEWED; NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT REGARDING POST-OPERATIVE INCISION NON-UNION AND EFFUSION FOR THIS ITEM# 01-3801, LOT# 234040. FOR THIS PART (01-3801) IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING POST-OPERATIVE INCISION NON-UNION AND EFFUSION, THERE IS A COMPLAINT RATE OF (B)(4) WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. POSSIBLE CAUSES FOR POST-OPERATIVE INCISION NON-UNION COULD INCLUDE NOT FOLLOWING PROPER WOUND CLOSURE TECHNIQUES, PATIENT CONDITION, OR ACTIVITY LEVEL. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00397. MEDICAL PRODUCTS: PECTUS SYSTEM 11IN PECTUS SUPPORT BAR, PART# 01-3711, LOT# 032170. PECTUS SYSTEM ELONGATED PECTUS STABILIZER, PART# 01-3801, LOT# 234040. (B)(6). THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS APPROXIMATELY TWO (2) WEEKS FOLLOWING IMPLANTATION OF A PECTUS SUPPORT BAR. THE PATIENT EXPERIENCED AN APPROXIMATELY TEN (10) ML EFFUSION AT THE SURGICAL INCISION, SWELLING, PAIN AND POOR WOUND HEALING. THE PATIENT IS BEING TREATED SYMPTOMATICALLY FOR SWELLING. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926217 PECTUS SYSTEM ELONGATED PECTUS STABILIZER PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 234040 00841036011093

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention SEE H10 NARRATIVE