BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECA

    MDR report key: 23933111 · Received December 31, 2025

    Report

    Report Number
    3010673777-2025-00049
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    June 3, 2025
    Report Date
    December 31, 2025
    Manufacturer
    NOVASTEP SAS
    Product Code
    HWC
    UDI-DI
    03700879513126
    PMA / PMN Number
    K143229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALL THE INFORMATION WE HAVE IS STATED IN THE REPORT WE RECEIVED; HOWEVER, IT INCLUDES AN INCORRECT PRODUCT REFERENCE AND AN INCORRECT LOT NUMBER. WE HAVE TRIED TO REACH OUT FOR THE PATIENT TO HAVE FURTHER INFORMATION, BUT WE HAD NO ANSWEARS THERFORE WE DO NOT HAVE ENOUGH INFORMATIONS TO INVESTIGATE FURTHER.

    Description of Event or Problem · 0

    WE HAVE RECEIVED A REPORT STATING THAT A PATIENT HAD A NOVASTEP SCREW (PECA COMPRESSIVE 4.0 X 60MM-SN/A, LOT NUMBER H0177A) IMPLANTED. DUE TO THE PAIN EXPERIENCED BY THE PATIENT, A VERIFICATION WAS PERFORMED, WHICH LED TO THE DISCOVERY THAT THE IMPLANT HAD BROKEN. A REVISION SURGERY IS PLANNED. NO FURTHER DETAILS HAVE BEEN COMMUNICATED TO US. MDR REPORT #: MW5178935. WE BELIVE A MISTAKE HAVE BEEN MADE THE SCREW WOULD BE: BEVELED COMPRESSIVE IMPLANT Ø4 LG60 THAT WOULD BE THE FOLLOWING REF: PS050160. ANOTHER DETAIL THAT WE WOULD LIKE TO CLARIFY WE DO NOT HAVE SUCH LOT NUMBER, THE LOT NUMBER H0177A DOES NOT EXIST FOR OUR PRODUCTS, THE CLOSEST BATCH NUMBER WOULD BE: H01775. THEREFORE, WE ARE UNABLE TO INVESTIGATE THIS ISSUE, AS WE DO NOT HAVE THE CORRECT REFERENCE OR THE APPROPRIATE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2634341 PECA BEVELED COMPRESSIVE IMPLANT Ø4 LG60 HWC NOVASTEP SAS PS050160 H01775 03700879513126

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other