BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-PLATE-RIGHT-REGULAR 2.0 LACTOSORB SYSTEM

    MDR report key: 7888799 · Received September 19, 2018

    Report

    Report Number
    0001032347-2018-00649
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    May 23, 2018
    Report Date
    February 21, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K971870
    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

    THE COMPLAINT IS CONSIDERED CONFIRMED AS THERE WAS A REVISION TO REMOVE THE IMPLANTS. THE L-PLATE RIGHT REG 2.0 LACTOSORB SYSTEM (PART# 915-2101, LOT# 050230) AND LACTOSORB SCREW 2.0X7MM 2.0 SYSTEM 2/PK (PART# 915-2301, LOT# 089260) COULD NOT BE VISUALLY EVALUATED OR FUNCTIONALLY TESTED DUE TO THE PRODUCTS NOT BEING RETURNED. THE REPORTED IMPLANT DATE WAS DEC 14, 2017 AND THE REMOVAL DATE WAS MAY 23, 2018 (ABOUT 5 MONTHS IMPLANTED). THE ALLEGED EVENT DATE WAS UNKNOWN. THE DISTRIBUTOR DID NOT MENTION A CAUSE OF THE PLATE EXPOSURE, BUT DID PROVIDE PHOTOS OF THE ALLEGED COMPLAINT. THE PARTS WERE CLEARLY FRACTURED AND THE ABSORPTION RATE APPEARED TO BE CONSISTENT WITH THE 4-5 MONTH IMPLANT TIME FRAME. NO PRODUCT WAS RETURNED, NO X-RAYS, SCANS OR PHYSICIAN REPORTS WERE PROVIDED, AND THE CAUSE OF THE PLATE EXPOSURE IS UNKNOWN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THESE REASONS, THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. 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. 5. THE DEVICES CAN BREAK OR BE DAMAGED DUE TO EXCESSIVE ACTIVITY OR TRAUMA. THIS COULD LEAD TO FAILURE OF THE PLATES AND/OR SCREWS WHICH COULD REQUIRE ADDITIONAL SURGERY AND DEVICE REMOVAL. THE IFU ALSO STATES IN THE SECTION TITLED PRECAUTIONS: 1. THE PATIENT IS TO BE WARNED THAT THE DEVICE CAN BREAK OR LOOSEN AS A RESULT OF STRESS, EXCESSIVE ACTIVITY OR LOAD BEARING. 2. THE PATIENT IS TO BE MADE AWARE OF THE SURGICAL RISKS AND POSSIBLE ADVERSE EFFECTS PRIOR TO SURGERY, AND WARNED THAT FAILURE TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS CAN CAUSE FAILURE OF THE IMPLANT AND THE TREATMENT. 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. THE FOLLOWING SECTIONS WERE UPDATED: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00654-1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS:.0001032347 - 2018 - 00654. (B)(4). (B)(6). 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS PLATE EXPOSURE FOUR MONTHS POST IMPLANTATION. THE DEVICE WAS INITIALLY IMPLANTED TO ADDRESS A MALAR BONE FRACTURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731727 L-PLATE-RIGHT-REGULAR 2.0 LACTOSORB SYSTEM PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 050230

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R 915-2301 SCREW LOT 089260| 915-2301 SCREW LOT 089260