BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMATRIX FENESTRATED 4 X 4CM

    MDR report key: 6773625 · Received August 8, 2017

    Report

    Report Number
    3004170064-2017-00008
    Event Type
    Injury
    Date Received
    August 8, 2017
    Report Date
    July 17, 2017
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    KGN
    PMA / PMN Number
    K153690
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON SEPTEMBER 11, 2017. RESULTS: THE FAILURE IS UNCONFIRMED, AS THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT. THEREFORE, FAILURE ANALYSIS COULD NOT BE PERFORMED. PER COMPLAINT DOCUMENTATION, THE PRIMATRIX DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR FAILURE ANALYSIS. DHR REVIEW; NO ANOMALIES WERE FOUND AND ALL MANUFACTURING RELATED PROCESS STEPS WERE FOLLOWED AND DOCUMENTED PER LISTED INSTRUCTIONS AND CURRENT GOOD MANUFACTURING PRACTICES. COMPLAINTS HISTORY; A QUERY OF THE COMPLAINTS DATABASE FOR THE TIMEFRAME OF (B)(6) 2016 ¿ (B)(6) 2017 WAS PERFORMED USING THE KEYWORDS : ¿PRIMATRIX,¿ ¿INFLAME,¿ ¿INFLAMMED,¿ ¿INFLAMMATION,¿ AND ¿INFLAM.¿ THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED DURING (B)(6) 2016 ¿ (B)(6) 2017. THERE WERE APPROXIMATELY 10,070 PRIMATRIX UNITS SOLD IN THE PAST 12 MONTHS BEFORE THIS COMPLAINT RESULTING IN A CALCULATED COMPLAINT OCCURRENCE RATE IS 0.01%. CONCLUSION: ROOT CAUSE IS INDETERMINABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT WHILE HE WAS ATTENDING A PMX ASSESSMENT FOR POSSIBLE REAPPLICATION, PATIENT'S WOUND AND PERI-WOUND WERE INFLAMED, THE DR. REMOVED THE FLUID AND SUGGESTED PATIENT HAVE AN X-RAY BECAUSE OF CONCERNS OF OSTEOMYELITIS. THE SALES REP CONTACTED THE DR. AND HE IMMEDIATELY SUGGESTED THAT PATIENT BE TAKEN TO OR, DEBRIDED AND CLEANED. HE PASSED ON THE RECOMMENDATION TO THE NP CLINICIAN. THEY DID NOT REAPPLY PMX. (PATIENTS WIFE IS A RN IN THE WCC). WHILE IN THE WCC ATTENDING A DIFFERENT PMX PATIENT, THE NURSE/WIFE (OF PATIENT) TOLD THE SALES REP THAT HER HUSBAND WAS ADMITTED TO HOSPITAL AND HAS OSTEOMYELITIS AND HAS HAD A PARTIAL FOOT AMPUTATION. SHE SAID ¿EVERYTHING WAS FINE WITH HIM UNTIL PRIMATRIX WAS APPLIED. THEN HE HAD PAIN ALL WEEK¿ SHE THEN WALK AWAY. SHE DID NOT SAY THAT PRIMATRIX WAS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555081 PRIMATRIX FENESTRATED 4 X 4CM PRIMATRIX KGN TEI BIOSCIENCES INC 1702063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other