MAUDE Adverse Event Report: SONENDO INC. SONENDO GENTLEWAVE SYSTEM; ULTRASONIC SCALER

Model Number	FG-002-00001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Sensitivity of Teeth (2427)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a necrotic tooth #18 for at least a year.The tooth was only symptomatic to the patient during percussion testing until recently when she was eating.Patient has lost other teeth to root fractures.The day of procedure, i instrumented all canals and began gw protocol.2min into the sodium cycle, she felt some discomfort.We stopped but found no leak or cause of the pain.She had felt pressure slowly building until it was pain.I tried once more and within a few seconds she felt the pain again.We stopped immediately, removed the platform, placed caoh and temporized.When anesthetic wore off that day she reported had pain that was constant and increased with biting pressure.She came back for an eval and percussion caused tenderness as well as pushing the tooth lingually.Based on symptoms, the dr.Suspected a vertical root fracture so checked again for any deep pocketing, found none and could see none on the inside or outside the tooth.Dr wanted to rule out the possibly of infection even though the symptoms weren't necessarily consistent with that.I placed her on clindamycin and symptoms stayed the same or increased slightly for about a week.Pt referred to specialist and radiologist for evaluation and cbct review; both found no issue.The tooth was extracted to resolve symptoms.

• Brand Name: SONENDO GENTLEWAVE SYSTEM
• Common Device Name: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO INC.; 26061 merit circle, suite 102; laguna hills, ca
• MDR Report Key: 9914501
• Report Number: 3010817521-2020-00004
• Device Sequence Number: 11465229
• Product Code: ELC
• UDI-Device Identifier: 00858395006226
• UDI-Public: 00858395006226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: FG-002-00001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other