BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR SURGICAL COVER TI FLA T 4.5MM IMP

    MDR report key: 8094228 · Received November 21, 2018

    Report

    Report Number
    0002023141-2018-00922
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Report Date
    April 1, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE SCR SURGICAL COVER TI FLA T 4.5MM IMP TSCW WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE COVER SCREW IS CUT LATERALLY AT THE DRIVE FEATURE DOWN TO THE HEX BASE. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. HOWEVER, A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE TSCW DATING BACK 2 YEARS. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS; 4869 REV 7-01/16; STEP 7 ¿ PREPARE THE IMPLANT FOR HEALING. THE COMPLAINT REPORTED THAT THE SCREW IS NOT DISENGAGING FROM THE IMPLANT. THE HEX DRIVER KEPT SLIPPING WHEN SHE WAS TRYING TO ENGAGE THE SCREW. SHE ORDERED A NEW DRIVER AND WAS STILL UNABLE TO REMOVE THE SCREW. THE REPORTED EVENT IS CONFIRMED FOLLOWING PHYSICAL EXAMINATION OF THE RETURNED DEVICE. A ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO¿ TO 'YES.' DEVICE EVALUATED BY MANUFACTURER: CHANGE 'NO' TO 'YES.'

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K NUMBERS: K013227 AND K953101. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COVER SCREW (TSCW) COULD NOT BE DISENGAGED FROM THE IMPLANT. THE PATIENT WAS REFERRED TO A SPECIALIST TO ATTEMPT RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936560 SCR SURGICAL COVER TI FLA T 4.5MM IMP SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1