BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 6791651 · Received August 14, 2017

    Report

    Report Number
    0001038806-2017-00496
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 18, 2017
    Report Date
    November 13, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INSPECTION. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: ZIMMER DENTAL: INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS (4894I REV. 3 ¿ 07/09) INFORMATION IDENTIFIED: WARNING IMPLANT SURGERY AND RESTORATION INVOLVE COMPLEX DENTAL PROCEDURES. APPROPRIATE AND ADEQUATE TRAINING IN PROPER TECHNIQUE IS STRONGLY RECOMMENDED PRIOR TO IMPLANT USE. IMPROPER TECHNIQUE CAN RESULT IN IMPLANT FAILURE AND/OR LOSS OF SUPPORTIVE BONE. PRECAUTIONS PROPER CASE PLANNING IS ESSENTIAL TO THE LONG-TERM SUCCESS OF BOTH THE PROSTHESIS AND THE IMPLANT. OVERLOAD IS ONE OF THE KEY CONTRIBUTORS TO IMPLANT FAILURE, PARTICULARLY IN THE MOLAR REGION WHERE OCCLUSAL LOADS ARE TYPICALLY THE HIGHEST. ENSURE THE IMPLANT SIZE AND ABUTMENT ANGULATION ARE APPROPRIATE FOR THE OCCLUSAL LOAD. HIGHLY ANGULATED ABUTMENTS SHOULD BE AVOIDED IN THE POSTERIOR REGION. CONTRAINDICATIONS NOT FOR USE WITH CEMENTED PROSTHESIS UNLESS A CUSTOM ABUTMENT IS FABRICATED. NOT FOR USE WITH NON-PRECIOUS METAL ALLOYS. NOT FOR USE IN MULTIPLE SPLINTED PROSTHETICS WHEN MORE THAN ONE GOLD BASE IS INVOLVED. PORCELAIN CANNOT BE BONDED DIRECTLY TO THE GOLD BASE PORTION OF THE COMPONENT. THE COMPLAINANT REPORTED THAT ¿WHEN HE WAS DELIVERING THE FINAL RESTORATION, THE RESTORATIVE SCREW STRIPPED¿. THE COMPLAINT COULD NOT BE VERIFIED, AS THE PRODUCT WAS NOT RETURNED. A ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT THE TIME OF EVEN IS UNKNOWN. PATIENT WEIGHT IS UNKNOWN. THIS DEVICE IS SOLD AS A BUNDLE ITEM WITH THE ABUTMENT AND ABUTMENT SCREW. ADDITIONAL 510K #'S - K013227, K953101. DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT ON (B)(6) 2017, WHEN HE WAS DELIVERING THE FINAL RESTORATION, THE RESTORATIVE/ABUTMENT SCREW (HLA3G) STRIPPED IN TOOTH LOCATION # 19. AFTER 5 HOURS, THE DENTIST AND LAB TECH WERE FINALLY ABLE TO SECTION THE CROWN TO ACCESS AND REMOVE THE SCREW. A HEALING CAP WAS PLACED AND THE PATIENT WILL RETURN ONCE THE RESTORATION HAS BEEN REMADE. THE PATIENT'S CONDITION WAS CONSIDERED DISTRAUGHT AT THE TIME OF THE EVENT BUT NO INJURY WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573382 ABUT GOLD FRICTION-FIT 3. 5MM IMP ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1