BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 7468301 · Received April 27, 2018

    Report

    Report Number
    0001038806-2018-00477
    Event Type
    Injury
    Date Received
    April 27, 2018
    Report Date
    August 20, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). NO PRODUCT WAS RETURNED FOR INSPECTION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT NUMBER. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: IFU-4869 REV 7 (01/16) - INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS WARNINGS: SURGICAL AND RESTORATIVE TECHNIQUES REQUIRED TO PLACE DENTAL IMPLANTS ARE HIGHLY SPECIALIZED AND COMPLEX PROCEDURES. PRACTITIONERS SHOULD ATTEND COURSES OF STUDY TO FAMILIARIZE THEMSELVES WITH IMPLANTOLOGY TECHNIQUES. IMPROPER TECHNIQUE CAN CAUSE BONE LOSS, PATIENT INJURY, PAIN AND IMPLANT FAILURE. ZIMMER DENTAL IMPLANT SYSTEMS ARE INTENDED TO BE USED ONLY WITH ZIMMER DENTAL SPECIALLY DESIGNED BONE DRILLS AND PROSTHETICS. IMPLANTS PLACED AT UNSUITABLE ANGLES RELATIVE TO EXISTING DENTITION OR MULTIPLE IMPLANTS PLACED AT CONVERGENT/DIVERGENT MANNER CAN RESULT IN COMPLEX RESTORATIONS THAT MAY OVERLOAD IMPLANTS, POTENTIALLY LEADING TO IMPLANT FAILURE (INCLUDING FRACTURE). A THOROUGH DIAGNOSTIC WORK-UP AND USE OF X-RAYS AND SURGICAL TEMPLATES ARE RECOMMENDED TO HELP ENSURE PROPER ANGULATION AND AVOIDANCE OF CERTAIN ANATOMICAL FEATURES SUCH AS SINUS MEMBRANES, ADJACENT TEETH AND CRANIOFACIAL NERVES. CONTRAINDICATIONS THE 3.7MMD ZIMMER TRABECULAR METAL IMPLANTS SHOULD NOT BE PLACED IN THE MOLAR REGION. ZIMMER DENTAL IMPLANTS SHOULD NOT BE PLACED IF THERE IS AN INSUFFICIENT VOLUME OF ALVEOLAR BONE TO MINIMALLY SUPPORT THE IMPLANT (MINIMUM 1MM CIRCUMFERENTIAL AND 2MM APICAL). IMPLANTS PLACED IN THE MAXILLA SHOULD NOT PERFORATE THE SINUS FLOOR MEMBRANE. POOR BONE QUALITY, POOR PATIENT ORAL HYGIENE, HEAVY TOBACCO USE, UNCONTROLLED SYSTEMIC DISEASES (DIABETES, ETC.), REDUCED IMMUNITY, ALCOHOLISM, DRUG ADDICTION, AND PSYCHOLOGICAL INSTABILITY MAY CONTRIBUTE TO LACK OF INTEGRATION AND/OR SUBSEQUENT IMPLANT FAILURE. SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE BONE LOSS, SCREW LOOSENING, COMPONENT FRACTURE, AND/OR IMPLANT FAILURE. EXPOSURE TO RADIATION AND CHEMOTHERAPY MAY IMPACT HEALTH OF THE IMPLANT. DENTAL IMPLANT PATIENTS SHOULD BE INSTRUCTED TO CONSULT WITH THEIR PHYSICIAN PRIOR TO UNDERGOING SUCH TREATMENT OPTIONS. TREATMENT PLANNING ADEQUATE PREOPERATIVE IMAGING AND DIAGNOSTIC EVALUATION ARE NECESSARY TO DETERMINE AVAILABLE BONE ANATOMY IN PROSPECTIVE IMPLANT SITES. THE LOCATION OF IMPORTANT ANATOMICAL LANDMARKS, SUCH AS THE MANDIBULAR CANAL, MAXILLARY SINUSES, CRANIOFACIAL NERVES AND ADJACENT TEETH, SHOULD BE ESTABLISHED PRIOR TO USE OF ZIMMER DENTAL IMPLANTS. CARE MUST BE TAKEN TO EVALUATE THE QUALITY AND QUANTITY OF THE RESIDUAL BONE, ESPECIALLY AFTER AN IMPLANT FAILURE AND WHEN IMPLANTS WILL BE IMMEDIATELY PLACED INTO EXTRACTION SITES. THOROUGH CLINICAL EVALUATION IS IMPERATIVE PRIOR TO ALL IMPLANT SURGERIES. NO RADIOGRAPHS WERE PROVIDED. WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. A SINGULAR CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    510K NUMBER K011028 AND K013227. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINUS WAS REPAIRED PRIOR TO IMPLANTATION. DOCTOR FOUND LESS VASCULARIZATION AND LESS DENSE BONE AFTER 6 MONTHS OF HEALING TIME HOWEVER HE PLACED IMPLANT. IT WAS ALSO REPORTED THAT THE IMPLANT (TSVWB10) LOSS INTEGRATION AND RELOCATED INTO THE SINUS. DOCTOR OPENED THE SINUS REMOVED THE IMPLANT AND RE-GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312060 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM IMPLANT DZE ZIMMER DENTAL 63245029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention