BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 LACTOSORB SYSTEM 1.5 X 4MM LACTOSORB SCREW

    MDR report key: 11609372 · Received April 2, 2021

    Report

    Report Number
    0001032347-2021-00185
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    January 14, 2021
    Report Date
    October 21, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    NHB
    UDI-DI
    00841036055189
    PMA / PMN Number
    K012409
    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. D4 AND H4- THREE (3) SCREW LOTS WERE USED IN THE IMPLANTATION SURGERY, AND IT IS UNKNOWN WHICH LOT WAS REMOVED IN THE REVISION. THE THREE (3) POSSIBLE LOTS ARE AS FOLLOWS: 1.5 LACTOSORB SYSTEM 1.5 X 4MM LACTOSORB SCREW, PART# 915-2315, LOT# 853160, MANUFACTURE DATE: 18 NOV 2019, EXPIRATION DATE: 18 NOV 2024, UDI NUMBER (B)(4). 1.5 LACTOSORB SYSTEM 1.5 X 4MM LACTOSORB SCREW, PART# 915-2315, LOT# 867550, MANUFACTURE DATE: 17 DEC 2019, EXPIRATION DATE: 17 DEC 2024, UDI NUMBER ((B)(4) 1.5 LACTOSORB SYSTEM 1.5 X 4MM LACTOSORB SCREW, PART# 915-2315, LOT# 867560, MANUFACTURE DATE: 08 JAN 2020, EXPIRATION DATE: 08 JAN 2025, UDI NUMBER (B)(4) . D10 ¿ MEDICAL PRODUCTS 1.5 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE, PART# 915-2414, LOT# 846230.

    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. 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. 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

    IT WAS REPORTED THE DEVICES WERE REMOVED DUE TO INFECTION THREE (3) MONTHS FOLLOWING IMPLANTATION. THREE (3) RESORBABLE PLATES WERE USED TO CLOSE A PEDIATRIC CRANIOTOMY. THE PATIENT COMPLAINED OF PUS AT THE PLATE FIXATION SITE AND ONE (1) PLATE WAS REMOVED IN A REVISION. A STRONG INFLAMMATORY REACTION WAS NOTED AT THE SCREW INSERTION POINT; THE BONE WAS DESCRIBED AS MELTED AND THE SCREW HOLE WAS LARGER. A CULTURE WAS SENT OUT AND STAPHYLOCOCCUS WAS NOTED. IT WAS PREDICTED THAT THE WOUND WOULD BE INFECTED AGAIN AND A REVISION WAS PLANNED TO REMOVE THE TWO (2) REMAINING PLATES TWO (2) MONTHS LATER, BUT THE DEVICE MATERIAL HAD ALREADY BEEN ABSORBED AND METABOLIZED. DEBRIDEMENT WAS PERFORMED TWICE AFTER WOUND INFECTION AND ANTIBIOTICS WERE USED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    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: 0001032347-2021-00184. CONCOMITANT MEDICAL PRODUCTS: 1.5 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE, PART# 915-2414, LOT# NI. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICES WERE REMOVED DUE TO INFECTION. THE DEVICES WERE USED TO CLOSE A CRANIOTOMY IN A PEDIATRIC CASE. THE PATIENT COMPLAINED OF PUS AT THE PLATE FIXATION SITE AND THE PLATE WAS REMOVED AT A LATER DATE. THE SAME SYMPTOM OCCURRED SEVERAL WEEKS AGO, AND THE PLATE HAS ALREADY BEEN REMOVED. THIS COMPLAINT OCCURRED IN THE REMAINING TWO PLACES WITH THREE FIXED POINTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505293 1.5 LACTOSORB SYSTEM 1.5 X 4MM LACTOSORB SCREW POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036055189

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R SEE H10 NARRATIVE| SEE H10 NARRATIVE