BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR*PMI 2025734 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT

    MDR report key: 10475092 · Received August 31, 2020

    Report

    Report Number
    0001032347-2020-00404
    Event Type
    Injury
    Date Received
    August 31, 2020
    Date of Event
    August 26, 2020
    Report Date
    March 31, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    UDI-DI
    00888233026000
    PMA / PMN Number
    K924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00404, 0001032347-2020-00405, 0001032347-2020-00406, 0001032347-2020-00430, 0001032347-2020-00431. D11 ¿ MEDICAL PRODUCTS HTR*PMI 2025734 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT, PART# PM623210-B, LOT# 986060 1.5MM SYSTEM 6 HOLE EXTRA LONG DOUBLE Y PLATE, PART# 01-7114, LOT# J416200 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK, PART# 91-6104, LOT# J416220 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCREW 1.5MM X 5MM, PART# 91-6105, LOT# NI 1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 1.8 X 5MM, PART# 91-1805, LOT# NI THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT B5 DESCRIBE EVENT OR PROBLEM D11 MEDICAL PRODUCT G4 DATE RECEIVED BY MANUFACTURER G7 TYPE OF REPORT H2 FOLLOW UP TYPE H10 ADDITIONAL NARRATIVES/DATA.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE INVESTIGATION CONDUCTED BY THE DESIGNER AND MANUFACTURER FOR ITEM# PM623210-B FOUND NO DEVIATIONS, NON-CONFORMITIES, OR ANOMALIES RELATED TO THE COMPLAINT. THE ISSUE WAS CONCLUDED TO NOT BE RELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED A CUSTOM CRANIOPLASTY PLATE WAS REMOVED DUE TO NECROSIS TWO (2) MONTHS AFTER IMPLANTATION. A FEW DAYS AFTER SURGERY, A BRUISE WAS OBSERVED IN THE SKIN OVER THE MIDDLE OF THE IMPLANT, AND THE BRUISE DID NOT IMPROVE. TWO (2) WEEKS PRIOR TO REMOVAL, THE SPOT ON THE SKIN OPENED UP WITH FLUID ESCAPING. IT HAS NOT BEEN DETERMINED IF THE BACK-UP IMPLANT WILL BE USED OR IF A NEW CUSTOM PLATE WILL BE IMPLANTED IN THE COMING MONTHS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED; 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 REPORTS: 0001032347-2020-00405, 0001032347-2020-00406. CONCOMITANT MEDICAL PRODUCTS: HTR*PMI 2025734 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT, PART# PM623210-B, LOT# 986060. 1.5MM SYSTEM 6 HOLE EXTRA LONG DOUBLE Y PLATE, PART# 01-7114, LOT# J416200. 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK, PART# 91-6104, LOT# J416220. UNKNOWN SCREWS, PART# NI, LOT# NI. TELEPHONE NUMBER: (B)(6). THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED A CUSTOM CRANIOPLASTY PLATE WAS REMOVED DUE TO NECROSIS TWO (2) MONTHS AFTER IMPLANTATION. A FEW DAYS AFTER SURGERY, A BRUISE WAS OBSERVED IN THE SKIN OVER THE MIDDLE OF THE IMPLANT, AND THE BRUISE DID NOT IMPROVE. TWO (2) WEEKS PRIOR TO REMOVAL, THE SPOT ON THE SKIN OPENED UP WITH FLUID ESCAPING. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939385 HTR*PMI 2025734 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT CUSTOM MADE DEVICE KKY BIOMET MICROFIXATION N/A 986060 00888233026000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R