BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 16MM

    MDR report key: 8344086 · Received February 15, 2019

    Report

    Report Number
    0001032347-2019-00125
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 18, 2019
    Report Date
    May 30, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K161896
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCTS WERE RETURNED FOR INVESTIGATION; THERE WAS LITTLE TO NO DAMAGE OBSERVED ON THE THREADS OF THE SCREWS. BECAUSE A REVISION SURGERY OCCURRED, THE COMPLAINT IS CONSIDERED CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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: 0001032347-2019-00124-1 & 0001032347-2019-00126-1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). DATE EXPLANTED: IT WAS REPORTED EXPLANTATION WILL TAKE PLACE ON THE (B)(6) 2019. THIS DATE HAS NOT BEEN CONFIRMED AT THIS TIME. CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM PLATE, 12 HOLE WIDE LADDER, CATALOG #: 73-2634, LOT #; NI; BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 14MM TITANIUM, CATALOG #: 73-2414, LOT #: NI. 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: 0001032347-2019-00124 AND 0001032347-2019-00126.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION IS PLANNED DUE TO THE PLATE LOOSENING. THE STERNUM CROSS FRACTURE WAS FIXED WITH A STERNA LOCK PLATE. INTRAOPERATIVELY AN X-RAY WAS PERFORMED TO CHECK IF THE SCREWS ARE BICORTICAL ANCHORED; TWO SCREWS WERE IN THE HINGE SPACE, HOWEVER A CORRECTION WAS NOT DESIRED. THE PLATE LOOSENED APPROXIMATELY FOUR WEEKS AFTER IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137998 STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 16MM BONE SCREW HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R