BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNALOCK BLU SYSTEM PLATE, 8 HOLE X

    MDR report key: 7504106 · Received May 10, 2018

    Report

    Report Number
    0001032347-2018-00266
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    April 9, 2018
    Report Date
    September 14, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK011076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THESE PARTS WERE REMOVED IN A REVISION, THEREFORE THE COMPLAINT IS CONSIDERED CONFIRMED. THE DISTRIBUTOR REPORTED THE DEVICES WERE REMOVED DUE TO BLEEDING, HE STATED THE DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE REVISION. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT CONDITION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00265-1.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW 2.4 X 16 MM CATALOG #: 73-2416 LOT #: NI. THERAPY DATE: (B)(6) 2018. 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 REPORT: 0001032347-2018-00265.

    Description of Event or Problem · 1

    IT WAS REPORTED A STERNAL REVISION WAS PERFORMED DUE TO THE PATIENT DEVELOPING A BLEED SIX DAYS POST-OPERATIVE. THE DISTRIBUTOR STATED THE DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344763 STERNALOCK BLU SYSTEM PLATE, 8 HOLE X BONE PLATE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R