BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7,10,MTX,MC,MG,HA

    MDR report key: 7722521 · Received July 26, 2018

    Report

    Report Number
    0002023141-2018-00638
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Report Date
    November 21, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). NO PRODUCT WAS RETURNED FOR INSPECTION. THE RETURNED X-RAY SHOWS THE REPORTED IMPLANT WITHIN THE SURGICAL SITE. NO SIGNS OF THREAD DAMAGE COULD BE IDENTIFIED FROM THIS IMAGE. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENT TYPE(S) REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 7-01/16 INFORMATION IDENTIFIED: BREAKAGE: IMPLANT AND ABUTMENT FRACTURES CAN OCCUR WHEN APPLIED LOADS EXCEED THE NORMAL FUNCTIONAL DESIGN TOLERANCES OF THE IMPLANT COMPONENTS. POTENTIAL OVERLOADING CONDITIONS MAY RESULT FROM SIGNIFICANT BONE LOSS (E.G. >3MM), DEFICIENCIES IN IMPLANT NUMBERS, LENGTHS AND/OR DIAMETERS TO ADEQUATELY SUPPORT A RESTORATION, EXCESSIVE CANTILEVER LENGTH, INCOMPLETE ABUTMENT SEATING, ABUTMENT ANGLES GREATER THAN 30 DEGREES, OCCLUSAL INTERFERENCES CAUSING EXCESSIVE LATERAL FORCES, PATIENT PARAFUNCTION (E.G. BRUXING CLENCHING), LOSS OR CHANGES IN DENTITION OR FUNCTIONALITY, IMPROPER CASTING PROCEDURES, INADEQUATE PROSTHESIS FIT, AND PHYSICAL TRAUMA. ADDITIONAL TREATMENT MAY BE NECESSARY WHEN ANY OF THE ABOVE CONDITIONS ARE PRESENT TO REDUCE THE POSSIBILITY OF BREAKAGE. COMPLAINT INDICATES IMPLANT THREAD DAMAGE FOLLOWING HEALING COLLAR INSERTION. THE ALLEGED EVENT WAS NON-VERIFIABLE WITHOUT THE RETURN OF THE PRODUCT AND WITH THE INFORMATION PROVIDED. A ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS WERE UPDATED: DATE OF THIS REPORT. MANUFACTURER. EXPIRATION DATE, UDI: (B)(4). CONTACT OFFICE - NAME/ADDRESS. OFFICE CONTACT - MANUFACTURING SITE. DATE RECEIVED BY MANUFACTURER. FOLLOW-UP NUMBER. FOLLOW UP TYPE. DEVICE EVALUATED BY MANUFACTURER: CHANGE NO TO YES. DEVICE MANUFACTURE DATE. EVALUATION CODES. ADDITIONAL NARRATIVE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    DATE OF THE EVENT UNKNOWN. REPORTER'S LAST NAME AND FAX NUMBER NOT PROVIDED. ADDITIONAL 510(K) NUMBER K133339.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL THREADS WERE STRIPPED ON THE IMPLANT (TSVMWH10). TOOTH LOCATION #19

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564659 IMP, TSV, 4.7,10,MTX,MC,MG,HA IMPLANT DZE ZIMMER DENTAL 63652844

    Patients

    Seq Age Sex Outcome Treatment
    1