BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND XTR

    MDR report key: 3832767 · Received May 27, 2014

    Report

    Report Number
    2024312-2014-00317
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    April 16, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K101423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DISCOVERED ON (B)(6) 2014 THAT THE DOCTOR HAD NOT REFRIGERATED THE OPTIBOND XTR PRODUCT, WHICH IS REQUIRED AS PER THE DIRECTIONS FOR USE. IT WAS INITIALLY REPORTED THAT THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND EVALUATIONS WERE PERFORMED ON A RETAINED SAMPLE; HOWEVER, THE OPTIBOND XTR PRODUCT (ADHESIVE (CATALOG #35108, LOT #4674868 AND PRIMER (CATALOG # 35107 AND LOT #4657224)) INVOLVED IN THE ALLEGED INCIDENT HAD BEEN RETURNED AND THE VISUAL EVALUATION WAS PERFORMED ON THE RETURNED SAMPLE, WHICH YIELDED RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THESE LOTS.

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. THE DOCTOR REPORTED THAT THE PATIENT HAD CONTACTED THE OFFICE WITHIN APPROXIMATELY THREE (3) DAYS OF PLACEMENT REPORTING SENSITIVITY ISSUES. THE DOCTOR HAD THE PATIENT RETURN TO THE OFFICE AND TOOK AN X-RAY; HOWEVER, NO ISSUES WITH THE RESTORATION WERE NOTED. THE DOCTOR REQUESTED THAT THE PATIENT WAIT 2-3 WEEKS TO SEE IF THE SENSITIVITY WOULD SUBSIDE; HOWEVER, AFTER WAITING THE REQUESTED TIME, THE SENSITIVITY WAS STILL PRESENT. THE DOCTOR HAD THE PATIENT RETURN TO THE OFFICE AND REPLACED THE PATIENT'S RESTORATIONS. NO TREATMENT DATES WERE PROVIDED. THE DOCTOR REPORTED THAT THE SENSITIVITY HAS BEEN REDUCED; HOWEVER, THE PATIENT IS STILL EXPERIENCING SOME SENSITIVITY. THE OPTIBOND XTR PRODUCT (ADHESIVE (CATALOG #35108, LOT #4674868) AND PRIMER (CATALOG # 35107 AND LOT #4657224)) INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, A VISUAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT ONE HUNDRED AND TWENTY (120) PATIENTS HAD EXPERIENCED SENSITIVITY AFTER RESTORATIONS WERE PLACED USING THE OPTIBOND XTR PRODUCT. THIS IS THE NINETEENTH OF ONE HUNDRED AND TWENTY (120) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310492 OPTIBOND XTR RESIN TOOTH BONDING AGENT KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R SONICFILL| (B)(4)