BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MMX10MM HT X-DR SCREW 5PK

    MDR report key: 19168398 · Received April 23, 2024

    Report

    Report Number
    0001032347-2024-00153
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    April 24, 2016
    Report Date
    April 23, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K001238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS : ITEM# 85-2410, LOT# NI, 2.4MMX10MM HT X-DR SCREW (B)(4) SCREWS. ITEM# 24-1060, LOT# NI, FRACTURE 16 HOLE QTY (B)(4). H2: FOREIGN: ARGENTINA NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT HAD A MEDICAL HISTORY INCLUDING OSSIFYING FIBROMA ILLNESS. THE PLATE WAS REMOVED DUE TO NECROSIS OF THE ILIAC CREST WITH AUTOGENOUS BONE GRAFT. NO INTRA-OPERATIVE COMPLICATIONS OR EVENTS. THE MEDICAL RECORDS WERE POOR QUALITY WITH PARTIALLY LEGIBLE HANDWRITING. AN IMAGE WAS ASSESSED BUT NOT SENT FOR RADIOLOGIST REVIEW AS THE IMAGE DATE IS NOT PROVIDED AND THE IMAGE IS OF POOR QUALITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THERE WAS A SURGICAL SITE INFECTION WITH BONE GRAFT FAILURE DUE TO NECROSIS AND A CONTRIBUTING FACTOR OF THE ISSUE WAS OSSIFYING FIBROMA/ILLNESS, HOWEVER, THIS COULD NOT BE CONFIRMED WITHOUT COMPLETE LEGIBLE MEDICAL RECORDS. THE REPORTED EVENT IS UNCONFIRMED. 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 THAT THE PATIENT WAS REVISED AS THERE WAS A SURGICAL SITE INFECTION WITH BONE GRAFT FAILURE DUE TO NECROSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943191 2.4MMX10MM HT X-DR SCREW 5PK SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Required Intervention| H