BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)

    MDR report key: 7084698 · Received December 5, 2017

    Report

    Report Number
    0001032347-2017-00844
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 15, 2017
    Report Date
    May 1, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK081067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT IS CONSIDERED TO BE CONFIRMED AS THERE WAS A REVISION. THE PRODUCT IDENTITIES WERE NOT CONFIRMED DUE TO THE PARTS NOT BEING RETURNED. THE IMPLANTS WERE REMOVED IN A REVISION AT THE PATIENT'S REQUEST. IT WAS REPORTED THAT THE PATIENT REQUESTED THIS REVISION IN RESPONSE TO A COMMENT MADE BY A RESIDENT THAT THE IMPLANT WAS "LIFTED SLIGHTLY OFF OF THE MANDIBLE". IT WAS ALSO REPORTED THAT THE SURGEON INDICATED THAT THERE WAS NO ISSUE RELATED TO THE IMPLANT. THE DEVICE HISTORY RECORDS OF THESE PRODUCTS COULD NOT BE REVIEWED DUE TO THE PART/LOT NUMBER REMAINING UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO CUSTOMER PREFERENCE. 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.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CATALOG NUMBER - IT IS UNKNOWN WHICH SCREWS WERE USED TO FIXATE THE LEFT MANDIBLE; POSSIBLE SCREWS USED ARE: CATALOG#: 41-2012, LOT #: NI. CATALOG#: 41-2312, LOT #: NI. CATALOG#: 41-2010, LOT #: NI. CATALOG#: 41-2310, LOT #: NI. MEDICAL PRODUCT:- OPM HTR PEKK CATALOG#: PK619318-B, LOT#: 041117. THERAPY DATE: (B)(6) 2017. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION WAS PERFORMED DUE TO THE PATIENT'S DISSATISFACTION WITH THE LEFT SIDE IMPLANT. A RESIDENT MENTIONED ONE OF THE FIXATION POINTS BEING "NOT QUITE RIGHT" ON THE X-RAY AND "LIFTED SLIGHTLY OFF OF THE MANDIBLE," HOWEVER THE SURGEON BELIEVES IT IS SECURE AND DID NOT AFFECT THE OUTCOME OF THE CASE. THE PATIENT REQUESTED THE REVISION BASED ON THE RESIDENT'S COMMENT. A NEW PATIENT MATCHED IMPLANT WAS MANUFACTURED AND THE REVISION WAS PERFORMED WITHOUT COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864228 FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) SCREW, FIXATION, BONE JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R