BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM LOCKING RECON SYSTEM HT CROSS-DRIVE LOCKING RECON SCREW,5/PK

    MDR report key: 9429243 · Received December 6, 2019

    Report

    Report Number
    0001032347-2019-00532
    Event Type
    Injury
    Date Received
    December 6, 2019
    Report Date
    April 24, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036060053
    PMA / PMN Number
    K113512
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS NON-VERIFIABLE. THE 2.4MMX16MMHT XDR LCK RCN SC5PK (PART# 85-2516, LOT# 333980) WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. THE DHR FOR THIS PRODUCT WAS REVIEWED; NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART (85-2516) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING REDNESS AND SWELLING POST-OP, THERE IS A COMPLAINT RATE OF 0.30% WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THIS IS THE ONLY COMPLAINT REGARDING REDNESS OR SWELLING FOR THIS PART# 85-2516, LOT# 333980. THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. 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. THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT B5 DESCRIBE EVENT OR PROBLEM D10 DEVICE AVAILABILITY G4 DATE RECEIVED BY MANUFACTURER G7 TYPE OF REPORT H2 FOLLOW UP TYPE H3 DEVICE EVALUATED BY MANUFACTURER H6 METHOD CODE H6 RESULTS CODE H6 CONCLUSIONS CODE H10 ADDITIONAL NARRATIVES/DATA

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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: 0001032347-2019-00529, 0001032347-2019-00530, 0001032347-2019-00531, 0001032347-2019-00532. IMPLANTATION DATE WAS IN (B)(6) 2019 CONCOMITANT MEDICAL PRODUCTS: 2.4MM LOCKING RECON SYSTEM 5X22 ANGLE LOCK RECON PLATE, RIGHT; PART# 24-4543; LOT# 607960; 2.4MM LOCKING RECON SYSTEM HT CROSS-DRIVE LOCKING RECON SCREW,5/PK; PART# 85-2508, LOT# 453890; 2.4MM LOCKING RECON SYSTEM HT CROSS-DRIVE LOCKING RECON SCREW,5/PK; PART# 85-2510; LOT# 808880; 2.4MM LOCKING RECON SYSTEM HT CROSS-DRIVE LOCKING RECON SCREW,5/PK, PART# 85-2516; LOT# 333980. INITIAL REPORTER: THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS EXPERIENCING FACIAL REDNESS AND SWELLING. THE PATIENT UNDERWENT A MANDIBULAR RECONSTRUCTION IN (B)(6) 2019 FOLLOWING A TUMOR RESECTION. ALLERGIC REACTION OR INFECTION ARE SUSPECTED BUT NEITHER ARE CONFIRMED. THE PATIENT HAS WEAKENED IMMUNITY DUE TO DRUG THERAPY AND RADIATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226966 2.4MM LOCKING RECON SYSTEM HT CROSS-DRIVE LOCKING RECON SCREW,5/PK SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A 333980 00841036060053

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention