BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED

    MDR report key: 10115321 · Received June 3, 2020

    Report

    Report Number
    0001032347-2020-00254
    Event Type
    Injury
    Date Received
    June 3, 2020
    Date of Event
    May 12, 2020
    Report Date
    November 17, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036054670
    PMA / PMN Number
    K992355
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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 CONSIDERED CONFIRMED BECAUSE A REVISION SURGERY WAS REPORTED. THE DEVICES WERE NOT RETURNED FOR INVESTIGATION AND NO PHOTOS WERE PROVIDED. FOR THESE REASONS, NO FUNCTIONAL TESTING OR VISUAL EVALUATIONS COULD BE CONDUCTED. NO X-RAYS, SCANS, PHOTOS, OR PHYSICIAN'S REPORTS WERE PROVIDED. THE DHR FOR THIS DEVICE WAS REVIEWED; NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT REGARDING EXTRUSION OF THE MATERIAL THROUGH SKIN FOR THIS ITEM# 915-2151, LOT# 957040. THE MOST LIKELY UNDERLYING CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE DEVICE WAS PLACED DIRECTLY UNDER THE INCISION, NEAR THE SKIN SURFACE. 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

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). 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 REPORT: 0001032347-2020-00255. CONCOMITANT MEDICAL PRODUCTS: 2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED, PART# 915-2151, LOT# 957040. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 369860. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: FOREIGN COUNTRY: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED A RE-OPERATION WAS PERFORMED DUE TO PLATE EXPOSURE FIVE (5) MONTHS FOLLOWING IMPLANTATION. THE PLATE HAD BEEN IMPLANTED ON THE MAXILLA AT A ZYGOMATIC FRACTURE DURING AN OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE AND FIVE (5) MONTHS LATER THE CORNER OF THE PLATE WAS EXPOSED. NO INFECTION WAS REPORTED TO HAVE OCCURRED AND THE PLATE WAS REMOVED IN A REVISION. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580277 2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 957040 00841036054670

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R SEE H10 NARRATIVE