BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBFIX BLU SCR S/D-LK 2.4X8MM

    MDR report key: 11723591 · Received April 26, 2021

    Report

    Report Number
    0001032347-2021-00216
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K142823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: RIBFIX BLU 8 HOLE STRAIGHT PLT CAT# 76-2601 LOT#NI. RIBFIX BLU 12 HOLE PREBENT PLT CAT# 76-2602 LOT#NI. RIBFIX BLU 12 HOLE PREBENT PLT CAT# 76-2602 LOT#NI. RIBFIX BLU SCR S/D-LK 2.4X8MM CAT# 76-2408 LOT#NI X QTY: (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347 - 2021 - 00212. 0001032347 - 2021 - 00213. 0001032347 - 2021 - 00214. 0001032347 - 2021 - 00215. 0001032347 - 2021 - 00217. 0001032347 - 2021 - 00218. 0001032347 - 2021 - 00219. 0001032347 - 2021 - 00220. 0001032347 - 2021 - 00221. 0001032347 - 2021 - 00222. 0001032347 - 2021 - 00223. 0001032347 - 2021 - 00224. 0001032347 - 2021 - 00225. 0001032347 - 2021 - 00226. 0001032347 - 2021 - 00227. 0001032347 - 2021 - 00228. 0001032347 - 2021 - 00229. 0001032347 - 2021 - 00230.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL RIBFIX BLU PROCEDURE, AFTER ONE PLATE HAD BEEN IMPLANTED, THE POSTERIOR END OF THE PLATE CAME OFF THE RIB AND PULLED THE 8MM SCREWS OUT. THIS IMPLANT WAS REMOVED AND THAT RIB WAS LEFT UNPLANTED. THE SURGEON THEN USED 12 HOLE IMPLANTS OVER THE NEXT TWO FRACTURES TO SPAN THE LOAD OVER THE RIBS. IN POSTOPERATIVE CT SCANS, IT WAS NOTICED THAT SCREWS HAD BEGUN TO BACK OUT AND ONE OF THE PLATES WAS GRADUALLY COMING OFF THE RIB. ADDITIONALLY, 4 NEW FRACTURES WERE FOUND. NO ADDITIONAL MEDICAL INTERVENTION IS PLANNED AT THIS TIME. 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
    624932 RIBFIX BLU SCR S/D-LK 2.4X8MM ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE HRS BIOMET MICROFIXATION N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other