BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTOSORB TRAUMA PLATING SYSTEM

    MDR report key: 6736694 · Received July 24, 2017

    Report

    Report Number
    0001032347-2017-00582
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 12, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK002083
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT STATES THE SCREW IS EITHER 915-2316 LOT 428300 OR 915-2318 LOT 578580. CATALOG # 915-2316, LOT # 428300, EXPIRATION DATE 08-2018, DEVICE MANUFACTURE DATE: 08-2013. CATALOG # 915-2318, LOT # 578580, EXPIRATION DATE 05-2018, DEVICE MANUFACTURE DATE: 05-2013. THE PACKAGE INSERT LISTS POSSIBLE ADVERSE EFFECTS: INFECTION CAN LEAD TO FAILURE OF THE PROCEDURE. NEUROVASCULAR INJURIES CAN OCCUR DUE TO SURGICAL TRAUMA. BENDING, FRACTURE, LOOSENING, RUBBING, AND MIGRATION OF THE DEVICES CAN OCCUR AS A RESULT OF EXCESSIVE ACTIVITY, TRAUMA OR LOAD BEARING. IMPLANTATION OF FOREIGN MATERIALS CAN RESULT IN AN INFLAMMATORY RESPONSE OR ALLERGIC REACTION. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00581.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. THIS IS SUPPLEMENTAL REPORT TWO OF TWO FOR THE SAME EVENT; REPORT ONE OF TWO IS REPORTED ON MFR #0001032347-2017-00581-1.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE PRODUCT IDENTITIES COULD NOT BE CONFIRMED AS ONLY FRAGMENTS WERE RETURNED. THE FRAGMENTS RETURNED WERE IN A BIOHAZARDOUS CONDITION AND CANNOT BE REMOVED FROM THEIR CONTAINER. A VISUAL INSPECTION OF THE RETURNED FRAGMENTS WAS CONDUCTED AND IT CANNOT BE DETERMINED THE RETURNED FRAGMENTS ARE LACTOSORB PRODUCTS. SINCE THE RETURNED FRAGMENTS ARE IN A BIOHAZARDOUS CONDITION A FURTHER INVESTIGATION BY REMOVING THE FRAGMENTS CANNOT BE COMPLETED. LACTOSORB HAS A TIME TO RE-ABSORPTION OF 12 MONTHS, AS THIS COMPLAINT IS 4 YEARS AFTER THE INITIAL IMPLANTATION IT IS UNLIKELY THAT THE REMAINING PRODUCT IS LACTOSORB. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE PATIENT¿S CONDITION. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. A SUMMARY OF THE INVESTIGATION WILL BE SENT TO THE COMPLAINANT. 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. THE FOLLOWING SECTIONS WERE UPDATED: DATE OF THIS REPORT, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT AND FOLLOW-UP NUMBER, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, ADDITIONAL NARRATIVES/DATA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2017-00581-2.

    Description of Event or Problem · 1

    THE PATIENT HAD AN INFECTION IN (B)(6)2016 WHICH CLEARED UP AFTER TWO MONTHS ON ANTIBIOTICS AND STEROIDS. THE PATIENT HAD INFRA-ORBITAL MARGIN SURGERY WHERE THE PLATE AND SCREWS WERE IMPLANTED ON (B)(6) 2013. THE PATIENT COMPLAINED OF PAIN AND IT WAS IDENTIFIED THE PATIENT HAD AN INFECTION. THE INFECTION DID NOT CLEAR UP WITH ANTIBIOTICS AND STEROIDS, THEREFORE A REVISION WAS PERFORMED (B)(6) 2017 TO REMOVE WHAT APPEARS TO BE FRAGMENTS OF THE PLATE AND/OR SCREWS THAT DID NOT COMPLETELY RESORB. IT IS REPORTED THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516660 LACTOSORB TRAUMA PLATING SYSTEM 1.5MM LACTOSROB SCREW JEY BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R