BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT FANTASTIC II TRACK MOUNT LIGHT

    MDR report key: 5048942 · Received September 2, 2015

    Report

    Report Number
    1017522-2015-00019
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    July 8, 2015
    Report Date
    August 5, 2015
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE DEVICE WAS NOT RETURNED TO PELTON & CRANE AS THE PELTON & CRANE DISTRIBUTOR HAD ALREADY REPAIRED THE DENTAL LIGHT BY REPLACING THE COUNTERBALANCE SPRING ASSEMBLY. HOWEVER, DURING FOLLOW-UP COMMUNICATION WITH THE DOCTORS OFFICE, THE REPLACED COUNTERBALANCE SPRING ASSEMBLY WAS STILL IN THE DR.'S POSSESSION THEREFORE PELTON & CRANE HAD THE PART RETURNED FOR EVALUATION. PELTON & CRANE RECEIVED THE COUNTERBALANCE SPRING ASSEMBLY AUGUST 19, 2015. UPON EVALUATION OF THE SPRING ASSEMBLY, IT WAS IDENTIFIED THAT THE TWO PIVOT STUDS LOCATED ON BOTH SIDES OF THE FRICTION BLOCK WERE BROKEN OFF DUE TO SUSPECTED EXCESSIVE LOADING THEREFORE THE SPRING ASSEMBLY COULD NOT COUNTERBALANCE THE LIGHT HEAD ASSEMBLY. THE PELTON & CRANE DENTAL TRACK LIGHT WAS MANUFACTURED TWENTY-SIX (26) YEARS AGO IN AUGUST 1989 AND IS PAST THE LIFE OF THE DEVICE. FURTHERMORE, DR. (B)(6) PURCHASED THE DENTAL TRACK LIGHT USED IN 2006 FROM ANOTHER DENTIST.

    Description of Event or Problem · 1

    A DENTAL HYGIENIST WAS PERFORMING ROUTINE DENTAL TREATMENT WITH A PATIENT WHEN A PELTON & CRANE LFTII DENTAL LIGHT COUNTER BALANCE ARM ASSEMBLY FAILED CAUSING THE LIGHT ARM TO DROP DOWN TOWARDS THE GROUND. THE LIGHT ARM DROPPED APPROXIMATELY ONE TO TWO FEET THEN STRUCK THE DENTAL ASSISTANT ON THE RIGHT SIDE OF HER HEAD. THE DENTAL ASSISTANT WENT TO THE HOSPITAL DUE TO FEELING PAIN AND WAS DIAGNOSED WITH A FRACTURE OF THE OCCIPITAL BONE AND A CONTUSION. THE DENTAL HYGIENIST STAYED IN THE HOSPITAL FOR TWO NIGHTS AND WAS THEN RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580870 LIGHT FANTASTIC II TRACK MOUNT LIGHT DENTAL LIGHT EAZ PELTON & CRANE HBT

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R