BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR-PMI KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT

    MDR report key: 7107591 · Received December 12, 2017

    Report

    Report Number
    0001032347-2017-00863
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    August 29, 2017
    Report Date
    August 6, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Adverse Event
    Yes
    Product Problem
    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. REPORTED EVENT WAS CONFIRMED BY REVIEW OF DEVICE HISTORY RECORDS AND PRE AND POST-SURGERY SCANS. THE DESIGN VENDOR CONDUCTED AN INVESTIGATION; DEVICE HISTORY RECORDS WERE REVIEWED AND NO ISSUES WERE DISCOVERED OTHER THAN A NOTE FROM CUSTOMER SERVICE STATING THE CUSTOMER UPLOADED PRE AND POST-SURGERY SCANS. THERE WAS A REQUEST FOR THE DESIGN TO USE THE PRE-SURGERY AND POST-SURGERY SCANS SENT TO CUSTOMER SERVICE NOTED IN THE WORK HISTORY DATABASE. HOWEVER, GENERIC SKULL MODEL DATA WAS USED INSTEAD. THIS WAS DUE TO THE DESIGNER NOT SEEING THE NOTE IN THE WORK HISTORY DATABASE STATING THAT PRE AND POST-SURGERY SCANS HAD BEEN RECEIVED AND TO USE THEM FOR THE DESIGN. A FAILURE TO NOT SEE THERE WERE PRE-SURGERY AND POST-SURGERY SCANS SENT IN RESULTED IN THE DESIGNER FOLLOWING THE PROCEDURE TO USE GENERIC ANATOMICAL DATA TO FILL IN THE DEFECT AREAS. THIS WAS A BI-LATERAL CASE; THE DESIGNER USED GENERIC ANATOMICAL DATA TO FILL IN THE DEFECT AREAS THAT BEST MATCHED THE CONTOUR OF THE PATIENT¿S SKULL. THE PRE-SURGERY AND POST-SURGERY SCANS SHOWED GREATER CURVATURE THAN THE GENERIC DATA USED. THE SWELLING OF THE PATIENT¿S BRAIN CAN ALSO CAUSE THE IMPLANTS TO FIT INCORRECTLY. SOFT TISSUE IS NOT REVIEWED IN THE HTR-PMI DESIGN PROCESS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE USE OF THE GENERIC DATA AND THE SWELLING OF THE BRAIN. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 REPORT: 0001032347-2017-00864-1.

    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 REPORT: 0001032347-2017-00864-2.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). (B)(4). CONCOMITANT MEDICAL PRODUCTS - ZIMMER BIOMET HTR-PMI CATALOG #: PM619804 LOT #: 776380. THERAPY DATE - (B)(6) 2017. FOREIGN COUNTRY - (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2017-00864.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANTATION OF BILATERAL HTR IMPLANTS, IT WAS NOTICED THAT THE IMPLANTS DID NOT FIT WITHOUT OVER-COMPRESSING THE BRAIN. IT IS STILL UNCLEAR WHETHER IT IS DUE TO THE SWELLING OF THE BRAIN OR THE IMPLANTS DESIGN BEING TOO FLAT. THE PRESUMPTION OF THE SURGEON IS THE IMPLANTS ARE TOO SHALLOW. DIFFERENT METHODS WERE USED TO ATTEMPT TO GET THE IMPLANTS TO FIT, THIS RESULTED IN A SURGICAL DELAY OF APPROXIMATELY 45 MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888482 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 Required Intervention