BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IS STRAIGHT CALIPERS

    MDR report key: 8879245 · Received August 9, 2019

    Report

    Report Number
    1526439-2019-51956
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 25, 2019
    Report Date
    July 25, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    KTZ
    UDI-DI
    10705034001333
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS A PCF (POSTERIOR CERVICAL FUSION) PROCEDURE TREATING CERVICAL MYELOPATHY ON (B)(6) 2019. THE THREAD OF THE STRAIGHT CALIPER (2050.37) CAME OFF AT THE BASE. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672775 IS STRAIGHT CALIPERS ORTHOPAEDIC BONE CALIPER KTZ DEPUY SPINE INC 10705034001333

    Patients

    Seq Age Sex Outcome Treatment
    1