BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT

    MDR report key: 9577846 · Received January 10, 2020

    Report

    Report Number
    0001032347-2020-00048
    Event Type
    Injury
    Date Received
    January 10, 2020
    Date of Event
    November 11, 2019
    Report Date
    June 29, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036141004
    PMA / PMN Number
    K011076
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS THERE WAS A REVISION SURGERY, THE COMPLAINT IS CONFIRMED. THERE ARE NO X-RAYS, SCANS, OR PHYSICIAN'S REPORTS AVAILABLE. A VISUAL INSPECTION WAS CONDUCTED AND THE PRODUCTS SHOW HEAVY WEAR. THE QTY THREE 73-1952 PLATES HAVE BEEN BENT AS WELL AS CUT. IT CANNOT BE DETERMINED IF THIS OCCURRED PRE OR POST OPERATION. THE SCREWS APPEARED TO HAVE DAMAGE ON THE LOCKING THREADS, WHICH COULD INDICATE THAT THEY DID NOT GET FULLY LOCKED INTO THE PLATE DURING INSERTION. THE DHR WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART (73-1952) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING THE SCREW COMING LOOSE POST OP, THERE IS A COMPLAINT RATE OF 0.09%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THIS IS THE ONLY COMPLAINT IN REGARDS THE SCREW BACKING OUT FOR 73-1952 LOT 948420. BECAUSE OF THE LACK OF INFORMATION, THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED, THOUGH IT IS POSSIBLE THE SCREWS WERE NOT FULLY INSERTED AND LOCKED INTO THE PLATE. 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.

    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). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001032347-2020-00047, 0001032347-2020-00049, 0001032347-2020-00050. MEDICAL PRODUCTS: STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT, PART# 73-1952, LOT# J143660, STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT, PART# 73-1952, LOT# 948420, 2.4MM STERNALOCK (TM) SYSTEM SELF-DRILLING SCREW, PART# 71-6410, LOT# UNK, 2.4MM STERNALOCK (TM) SYSTEM SELF-DRILLING SCREW, PART# 71-6412, LOT# UNK. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: SPAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE STERNAL PLATE FRACTURED AND SCREWS BACKED OUT OF A PLATE SEVEN MONTHS POST-OPERATIVELY. IN (B)(6) 2019, THREE PLATES AND TEN SCREWS WERE IMPLANTED IN A RAVITCH PROCEDURE CORRECTING PECTUS EXCAVATUM. IN (B)(6) 2019, THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW PLATES AND SCREWS. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE REVISION SURGERY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37720 STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 948420 00841036141004

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R