BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW

    MDR report key: 11872466 · Received May 24, 2021

    Report

    Report Number
    0001032347-2021-00286
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 6, 2021
    Report Date
    January 26, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036055028
    PMA / PMN Number
    K002083
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION B4, B5, D1, D4, D9, G3, G6, H1, H2, H6 AND H10. IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS POSTOP, THE PATIENT PRESENTED WITH SIGNS OF INFECTION DURING THE RESORPTION STAGE OF THE IMPLANT. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. UPON REASSESSMENT OF THE REPORTED EVENT BASED ON ADDITIONAL INFORMATION. THIS PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS INITIAL REPORT SUBMITTED NEEDS TO BE VOIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    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 REPORTS: 0001032347-2021-00283, 0001032347-2021-00284, 0001032347-2021-00285, 0001032347-2021-00287, 0001032347-2021-00288, 0001032347-2021-00289, 0001032347-2021-00290, 0001032347-2021-00291, 0001032347-2021-00292, 0001032347-2021-00293, 0001032347-2021-00294, 0001032347-2021-00295, 0001032347-2021-00296, 0001032347-2021-00297, 0001032347-2021-00298, 0001032347-2021-00299, 0001032347-2021-00300. MEDICAL PRODUCTS: 2.0 LACTOSORB SYSTEM L-PLATE - LEFT - REGULAR, PART# 915-2102, LOT# 847100. 2.0 LACTOSORB SYSTEM L-PLATE - LEFT - REGULAR, PART# 915-2102, LOT# 847100. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849260. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849260. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849260. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849260. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849260. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849260. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849260. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849280. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849280. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849280. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 849280. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 850040. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 850040. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 850040. 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW, PART# 915-2301, LOT# 850040. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION NINE (9) MONTHS FOLLOWING FIXATION WITH RESORBABLE IMPLANTS AFTER A MAXILLARY OSTEOTOMY OF THE UPPER LEFT JAW. DURING THE RESORPTION STAGE, THE PATIENT¿S GUMS WERE SWOLLEN AND PUS WAS EXCRETED. THE SURGEON IS MONITORING THE PATIENT AND NO REVISION IS PLANNED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769181 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW PLATE, BONE JEY BIOMET MICROFIXATION N/A 849260 00841036055028

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other