BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW

    MDR report key: 11624479 · Received April 6, 2021

    Report

    Report Number
    0001032347-2021-00171
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 17, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036055196
    PMA / PMN Number
    K002083
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00169, 0001032347-2021-00170, 0001032347-2021-00172, 0001032347-2021-00173, 0001032347-2021-00174. CONCOMITANT MEDICAL PRODUCTS: 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW, PART# 915-2316, LOT# 595560, 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW, PART# 915-2316, LOT# 595560, 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW, PART# 915-2316, LOT# 595560, 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW, PART# 915-2316, LOT# 595560, 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW, PART# 915-2316, LOT# 595560. REPORT SOURCE FOREIGN: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIX (6) SCREWS FRACTURED UPON IMPLANTATION. THE SCREWS WERE USED ON THE INFRAORBITAL MARGIN AND ZYGOMATIC FRONTAL SUTURE. THE SURGEON THOUGHT HE WAS NOT INSERTING THE SCREW DIAGONALLY BECAUSE IT WAS THE LOWER EDGE AND THE SUTURE. THE SURGEON ALSO THOUGHT IT WAS STRANGE THAT THE EVENT OCCURRED EVEN IF THE PATIENT¿S BONES WERE HARD. THE MALFUNCTIONS CAUSED A DELAY GREATER THAN THIRTY (30) MINUTES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522103 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW PLATE, BONE JEY BIOMET MICROFIXATION N/A 595560 00841036055196

    Patients

    Seq Age Sex Outcome Treatment
    1