MAUDE Adverse Event Report: DENTSPLY CAVITRON JET PLUS

Device Problem Insufficient Information (3190)

Patient Problems Tinnitus (2103); Vertigo (2134); Discomfort (2330); Injury (2348)

Event Date 09/19/2013

Event Type  Injury  

Event Description

I had a routine check-up and cleaning at the offices of my dentist.Dr (b)(6).Her hygienist, (b)(6), used an ultrasonic scaler made by dentsply- the dentsply cavitron jet plus, according to dr (b)(6).When (b)(6) was scaling my molars on each side, my ear on that side hurt.After the appointment, i had problems with my ears that i had not previously experienced in my nearly (b)(6) years: 1- unusual discomfort in my inner ears, on both sides, without any symptoms of ear infection; 2- for the first several days after the cleaning, tinnitus and 3- most significantly, my vestibular system ceased functioning properly, as it had before the scaling.The worst damage was in the posterior canal that registers pitch of the head forward and back.Every time my head went from horizontal, especially face-up, to vertical, i got incredibly off-balance, to the point where i had to steady myself with whatever i could grab.I almost fell off a dock.I walked to the right when trying to walk straight.I saw a top-rated otolaryngologist in (b)(6).She diagnosed me with benign paroxysmal positional vertigo ("bppv")-- vertigo of the kind that commonly ensues from head trauma, and, in this case, it seems, from an ultrasonic dental scaler.(b)(6) and other good hospitals have good explanations online.Makes sense that ultrasound could dislodge minute calcium crystals from the utricle.The manual for the scaler provides the practitioner deficient info on the amplitude of the ultrasonic scaler at various settings on the power dial, with and without the "boost" and "turbo" settings.I requested this info from dentsply, through their general counsel.Dentsply acknowledged receipt but did not provide the requested info, so i was unable to provide it to the otolaryngologist.My bppv has been getting better.The fda should nonetheless take this matter seriously.If i had lost my balance while operating heavy machinery or walking in traffic, for example, i might easily have been seriously injured or killed.Others may not be so lucky.

• Brand Name: CAVITRON JET PLUS
• Type of Device: CAVITRON JET PLUS
• Manufacturer (Section D): DENTSPLY
• MDR Report Key: 3588904
• MDR Text Key: 20294864
• Report Number: MW5033918
• Device Sequence Number: 1
• Product Code: ELC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Weight: 77