BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW, 1.5X4MM

    MDR report key: 8403796 · Received March 8, 2019

    Report

    Report Number
    0001032347-2019-00159
    Event Type
    Injury
    Date Received
    March 8, 2019
    Report Date
    July 22, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBW
    UDI-DI
    00841036053734
    PMA / PMN Number
    K121624
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF EVIDENCE THAT THE REVISION WAS PERFORMED. NO PRODUCT WAS RETURNED AND NO TEST OR INSPECTIONS COULD BE PERFORMED. THE REASON FOR THE REVISION WAS DUE TO INFECTION. THE DISTRIBUTOR PROVIDED TWO POST-OPERATIVE CT SCANS FROM THE IMPLANTATION SURGERY. UPON REVIEW OF THE CT SCANS, NO CONCLUSIONS COULD BE REACHED IN REGARDS TO THE INFECTION. THE DISTRIBUTOR SUGGESTED IT MAY HAVE BEEN CAUSED FROM A WOUND CREATED WHEN THE PHYSICIAN TRIED TO PLACE THE IMPLANT. HOWEVER, THIS COULD NOT BE CONFIRMED BASED ON THE MATERIALS PROVIDED. DHR AND STERILE CERTIFICATES WERE REVIEWED AND NO DISCREPANCIES OR NOR ANOMALIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00158-1 AND 0001032347-2019-00160-1.

    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). DEVICE PRODUCT CODE: HBW. IMPLANT DATE: (B)(6) 2019. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00158 AND 0001032347-2019-00160.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A WOUND WHERE THE AREA DID NOT FIT AND THAT WOUND WAS INFECTED. THE IMPLANT WAS REPLACED AND NOW EVERYTHING IS FINE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196457 1.5 MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW, 1.5X4MM FASTENER, SCREW, CRANIOPLASTY HBW BIOMET MICROFIXATION N/A 994450 00841036053734

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R