BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTOSORB SYSTEM 2.0 X 5 MM SUSPENSION PUSH SCREW2-PACK

    MDR report key: 7842828 · Received September 4, 2018

    Report

    Report Number
    0001032347-2018-00589
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    August 2, 2018
    Report Date
    January 9, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    MBI
    PMA / PMN Number
    PK013557
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE 2.0X5MM SUS PUSH SCREW 2/PK (PART# 915-2336, LOT# 551540) WAS RETURNED IN A RED BIOHAZARD BAG. THE SCREWS WERE REMOVED FOR VISUAL EVALUATION. ONE OF THE TWO SCREWS APPEARED TO BE UNUSED. THE OTHER SCREW ONLY HAD THE HEX HEAD RETURNED. THE SCREW WAS FRACTURED OFF AT THE MINOR DIAMETER BETWEEN THE HEX HEAD AND THE SCREW HEAD. THE PUSH SCREW ITSELF WAS NOT RETURNED. THE HEX HEAD APPEARED TO HAVE SOME DARK RED RESIDUE ON IT, LIKELY BLOOD AS THE COMPLAINT STATES AN ATTEMPT WAS MADE TO USE IT IN A PROCEDURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE DEVICE EXPERIENCED EXCESSIVE FORCE DURING INSERTION. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A SCREW FRACTURED DURING AN ENDOBROW LIFT PROCEDURE. THE SURGEON ATTEMPTED TO INSERT THE SCREW IN A PRE-DRILLED HOLE, HOWEVER IT FRACTURED JUST BELOW THE HEAD. THE SURGEON WAS ABLE TO REMOVE THE SCREW WITHOUT ANY ADDITIONAL DRILLING OR BURRING AND A NEW SCREW WAS INSERTED IN THE SAME HOLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684499 LACTOSORB SYSTEM 2.0 X 5 MM SUSPENSION PUSH SCREW2-PACK FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BIOMET MICROFIXATION N/A 551540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention