BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR-PMI KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT

    MDR report key: 7107608 · Received December 12, 2017

    Report

    Report Number
    0001032347-2017-00866
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    October 11, 2017
    Report Date
    August 6, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00867-2, 0001032347-2017-00868-2, AND 0001032347-2017-00869-2.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DISTRIBUTOR REPORTED THAT THESE PARTS WERE REMOVED IN A REVISION DUE TO INFECTION; THEREFORE THE COMPLAINT IS CONSIDERED CONFIRMED. THERE WAS NO ALLEGED MALFUNCTION OF THE IMPLANTS. DEVICE HISTORY RECORDS (DHR'S) WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED FOR THE UNKNOWN SCREWS AS THE CATALOG NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT CONDITION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00867-1, 0001032347-2017-00868-1, AND 0001032347-2017-00869-1.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN COUNTRY - (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCT S: ZIMMER BIOMET HTR-PMI, CATALOG #:PM619804, LOT #: 776380; ZIMMER BIOMET THINFLAP PLATE, CATALOG #: SP-2046, LOT #: 415630; ZIMMER BIOMET 1.5 SCREW, CATALOG #: 91-6704, LOT #: 140670; UNKNOWN SCREWS, CATALOG #: NI, LOT #: NI, THERAPY DATE: (B)(6) 2017. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00867 THROUGH 0001032347-2017-00869.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GOAL WAS TO IMPLANT BOTH LEFT AND RIGHT IMPLANTS DURING ONE PROCEDURE, HOWEVER IT WAS ONLY POSSIBLE TO PLACE ONE IMPLANT DUE TO THE BRAIN SWELLING. IT IS UNKNOWN WHICH SIDE WAS ABLE TO BE IMPLANTED, THEREFORE IT IS UNKNOWN WHICH IMPLANT WAS REMOVED DURING THIS REVISION. IN REGARDS TO PATIENT OUTCOME, IT WAS REPORTED THE SECOND SET OF IMPLANTS WERE ABLE TO BE IMPLANTED AND THEY FIT.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION WAS PERFORMED DUE TO AN INFECTION. IT IS STATED THE INFECTION HAS NOTHING TO DO WITH THE IMPLANTS. A REQUEST WAS RECEIVED FOR NEW HTR PMI IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888705 HTR-PMI KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT KKY BIOMET MICROFIXATION N/A 776370

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R