BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARCORRECT SYSTEM/ALIGNERS

    MDR report key: 4210298 · Received October 17, 2014

    Report

    Report Number
    3007130440-2014-00007
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 16, 2014
    Manufacturer
    CLEARCORRECT,LLC
    Product Code
    NXC
    PMA / PMN Number
    K113618
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: PROVIDER REPORTED THAT THE PATIENT WAS DEVELOPING A RASH WITH THEIR MOUTH AND SUBMITTED PICTURES AS EVIDENCE. PREVIOUS PHASE SHIPPED DID NOT RESULT IN AN ADVERSE EVENT AND THE PROVIDER BELIEVED THAT THE PRODUCT WAS DEFECTIVE. INVESTIGATION OF THE PRODUCTIONS LINE PROVED THAT NO PROTOCOL OR OTHER CHANGES (SUCH AS CHANGE IN MATERIAL, CLEANING SOLUTION, OR OTHER METHODS OF MANUFACTURE) SINCE PREVIOUS SHIPMENTS ((B)(4) 2013 AND (B)(4) 2014) THAT COULD HAVE LED TO THE DEVELOPMENT OF MUCOSAL IRRITATION. REQUESTED PRODUCT WAS RETURNED TO (B)(4) 2014 AND INSPECTED. PRODUCT CONFORMED TO INSPECTION PROTOCOLS. ORIGINAL DENTAL IMPRESSIONS WERE FOUND TO BE DISTORTED AT THE OCCLUSAL AND DISTAL MOLAR REGIONS FOR BOTH ARCHES AND THAT THE PATIENT HAS A CALCIUM BUMP THAT COULD HAVE BEEN IRRITATED BY THE ALIGNER. CASE IS CURRENTLY ON HOLD UNTIL PROVIDER AND PATIENT DETERMINE TO CONTINUE OR PERMANENTLY DISCONTINUE TREATMENT. MANUFACTURE NARRATIVE SUMMARY: ON (B)(6) 2014 PROVIDER INFORMED SUPPORT REP THAT THE PATIENT HAD DEVELOPED MUCOSAL IRRITATION AND PROVIDED PICTURES OF THE INFECTED AREAS OF THE PATIENT'S MOUTH. PROVIDER STATED THE PATIENT DID NOT HAVE ANY SIMILAR EVENTS WITH THE PREVIOUS ALIGNERS THAT SHIPPED ON (B)(4) 2013 AND (B)(4) 2014. SUPPORT REP INSTRUCTED THE PROVIDER TO RETURN THE PRODUCT THAT THEY BELIEVED IT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AND TO DISCONTINUE TREATMENT UNTIL COMPLETION OF QUALITY CONTROL INVESTIGATION. PRODUCTION LINE WAS IN WAS INVESTIGATED TO DETERMINE IF THERE HAD BEEN ANY CHANGES SINCE PREVIOUS SHIPMENTS FOR THIS PATIENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. THE INVESTIGATION FOUND THAT THERE HAD BEEN NO CHANGES THAT COULD LEAD TO THE PATIENT DEVELOPING A RASH AND RETURNED PRODUCTS SHOWED NO MANUFACTURING DEFECTS. CASE IS CURRENTLY ON HOLD UNTIL PROVIDER AND PATIENT DETERMINE TO CONTINUE OR PERMANENTLY DISCONTINUE TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014 PROVIDER INFORMED SUPPORT REP THAT THE PATIENT HAD DEVELOPED MUCOSAL IRRITATION AND PROVIDED PICTURES OF THE INFECTED AREAS OF THE PATIENT'S MOUTH. PROVIDER STATED THE PATIENT DID NOT HAVE ANY SIMILAR EVENTS WITH THE PREVIOUS ALIGNERS THAT SHIPPED ON (B)(4) 2013 AND (B)(4) 2014. SUPPORT REP INSTRUCTED THE PROVIDER TO RETURN THE PRODUCT THAT THEY BELIEVED IT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AND TO DISCONTINUE TREATMENT UNTIL COMPLETION OF QUALITY CONTROL INVESTIGATION. PRODUCTION LINE WAS INVESTIGATED TO DETERMINE IF THERE HAD BEEN ANY CHANGES SINCE PREVIOUS SHIPMENTS FOR THIS PATIENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. THE INVESTIGATION FOUND THAT THERE HAD BEEN NO CHANGES THAT COULD LEAD TO THE PATIENT DEVELOPING A RASH AND RETURNED PRODUCTS SHOWED NO MANUFACTURING DEFECTS. CASE IS CURRENTLY ON HOLD UNTIL PROVIDER AND PATIENT DETERMINE TO CONTINUE OR PERMANENTLY DISCONTINUE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663526 CLEARCORRECT SYSTEM/ALIGNERS CLEAR PLASTIC ORTHODONTIC ALIGNER NXC CLEARCORRECT,LLC PHASE 4 0811204-33701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention