BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI-DBLE LEAD CORT 5.0X40MM SCR

    MDR report key: 8398379 · Received March 7, 2019

    Report

    Report Number
    0001825034-2019-00990
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    September 1, 2018
    Report Date
    August 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K063570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00989, 0001825034-2019-00990, 0001825034-2019-00991, 0001825034-2019-00993, 0001825034-2019-00994. CONCOMITANT MEDICAL PRODUCTS: ANKLE LOCKING NAIL 11 X 150MM PN: 14-440215 LN: 838730. TI-DBLE LEAD CORT 5.0X40MM SCR PN: 14-405040 LN: 471730. TI-DBLE LEAD CORT 5.0X46MM SCR PN: 14-405046 LN: 482100. TI-DBLE LEAD CORT 5.0X70MM SCR PN: 14-405070 LN: 742180. TI-DBLE LEAD CORT 5.0X32MM SCR PN: 14-405032 LN: 425110. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO FRACTURE AND NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193230 TI-DBLE LEAD CORT 5.0X40MM SCR ROD, FIXATION HSB ZIMMER BIOMET, INC. 471730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R