BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW

    MDR report key: 7804430 · Received August 22, 2018

    Report

    Report Number
    0001032347-2018-00562
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 11, 2018
    Report Date
    January 8, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK971870
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED AND NO PHOTOGRAPHS BEING PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT STATES IN THE SECTION TITLED WARNINGS: 1. IMPROPER SELECTION, PLACEMENT, POSITIONING, OR FIXATION OF THE IMPLANT CAN CAUSE A SUBSEQUENT UNDESIRABLE RESULT. DEVICES SHOULD NOT BE LOCATED DIRECTLY UNDER A SUTURE SITE. THE SURGEON IS TO BE FAMILIAR WITH THE DEVICES, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: DEVICE PRODUCT CODE CORRECTED TO HRS. PMA/510(K) NUMBER CORRECTED TO K971870.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ONE OF FOUR SCREWS FRACTURED WHILE INSERTING DURING A PROCEDURE. THE SURGEON FOLLOWED THE NORMAL PROCESS. THE AREA WAS ON ZYGOMATIC BONE, IN BLEEDING FRACTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647057 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW RESORBABLE SCREW, BONE HRS BIOMET MICROFIXATION N/A 089000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention