BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 LACTOSORB SYSTEM CURVED PLATE 6 HOLE

    MDR report key: 9525242 · Received December 27, 2019

    Report

    Report Number
    0001032347-2019-00584
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    October 23, 2019
    Report Date
    May 29, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036054434
    PMA / PMN Number
    K955729
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE CUR PLT 6HL 2.0 LACTOSORB SYS (PART# 915-2103, LOT# 633300) WAS NOT RETURNED FOR INVESTIGATION AS IT WAS ALREADY ABSORBED AND COULD NOT BE REMOVED. THERE WAS NO INFORMATION REGARDING CULTURES OR ALLERGIES. THE DHRS FOR THESE IMPLANTS WERE REVIEWED; NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT REGARDING AN ALLERGIC REACTION, INFECTION, OR INFLAMMATION FOR THIS PART# 915-2103, LOT# 633300. FOR THIS PART (915-2103) AND THE PREVIOUS THREE YEARS (FROM THE NOTIFICATION DATE) REGARDING AN ALLERGIC REACTION, INFECTION, OR INFLAMMATION, THERE IS A COMPLAINT RATE OF 0.42% WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. DUE TO THE LOW SALES OF THIS PART, THE RANGE OF COMPLAINTS AND SALES DATA THAT WAS REVIEWED WAS EXTENDED FROM ONE YEAR TO THREE YEARS. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT COULD NOT 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. THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT B5 DESCRIBE EVENT OR PROBLEM D10 DEVICE AVAILABILITY G4 DATE RECEIVED BY MANUFACTURER G7 TYPE OF REPORT H2 FOLLOW UP TYPE H3 DEVICE EVALUATED BY MANUFACTURER H6 METHOD CODE H6 RESULTS CODE H6 CONCLUSIONS CODE H10 ADDITIONAL NARRATIVES/DATA.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; 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: 0001032347-2019-00583, 0001032347-2019-00585. CONCOMITANT MEDICAL PRODUCTS: 1.5 LACTOSORB SYSTEM X-PLATE REGULAR, PART# 915-2422, LOT# 131070; 2.0 LACTOSORB SYSTEM CURVED PLATE 6 HOLE, PART# 915-2103, LOT# 633300; 2.0 LACTOSORB SYSTEM STRAIGHT PLATE 4 HOLE, PART# 915-2110, LOT# 050460. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE ¿ (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED REDNESS TEN MONTHS POST-OPERATIVELY FOLLOWING THE IMPLANTATION OF ABSORBABLE PLATES IN THE LOWER ZYGOMATIC AREA. A REVISION SURGERY WAS PERFORMED BUT THE PLATES WERE ABSORBED SO THE IMPLANTS COULD NOT BE REMOVED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319100 2.0 LACTOSORB SYSTEM CURVED PLATE 6 HOLE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 633300 00841036054434

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R