BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVAK 13.5" TI PECTUS BAR

    MDR report key: 11731700 · Received April 27, 2021

    Report

    Report Number
    0001032347-2021-00204
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 17, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K061384
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PECTUS BAR IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: TWO VIEWS OF THE CHEST DEMONSTRATE POSTOPERATIVE CHANGES FROM RECONSTRUCTION OF A PECTUS EXCAVATUM PROCEDURE WITH DISLODGMENT OF THE PECTUS BAR FROM THE STABILIZER ON THE LEFT SIDE OF THE PATIENT. THE OVERALL FIT OF THE IMPLANT IS APPROPRIATE. NO CORRELATING FACTORS CAN BE IDENTIFIED FOR THE DISLODGEMENT OF THE PECTUS BAR FROM THE STABILIZER ON THE LEFT SIDE OF THE PATIENT. THE PATIENT OP NOTES WERE REVIEWED: THE PATIENT WAS DIAGNOSED WITH HAVING SEVERE PECTUS EXCAVATUM. SHE HAD WORSENING SHORTNESS OF BREATH AND CHEST DISCOMFORT OVER A PERIOD OF SEVERAL MONTHS PRIOR TO THE PROCEDURE. SHE HAD NO SIGNIFICANT SYMPTOMS SINCE CHILDHOOD AND DID NOT CONSIDER SURGICAL REPAIR UNTIL NOW. MORE RECENTLY, SHE HAS BEEN UNABLE TO DO HER ACTIVE EXERCISES BECAUSE OF SHORTNESS OF BREATH AND CHEST DISCOMFORT. 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 MEDICAL PRODUCTS: QTY: 2 : TITANIUM PECTUS ELONGATED STAB, CAT# 01-3802, LOT#NI. 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 - 2021 - 00205, 0001032347 - 2021 - 00206.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PECTUS BAR AND TWO STABILIZERS WERE EXPLANTED APPROXIMATELY TWO MONTHS POSTIMPLANTATION DUE TO DISLOCATION OF THE BAR FROM THE STABILIZER. THE SURGEON PLANS ON REINSERTION IN THE NEAR FUTURE. 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
    629560 NOVAK 13.5" TI PECTUS BAR FUNNEL CHEST REMODELING BAR HRS BIOMET MICROFIXATION N/ 029680

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R SEE H10