MAUDE Adverse Event Report: PROSOMNUS SLEEP TECHNOLOGIES PROSOMNUS EVO SLEEP AND SNORE DEVICE; MANDIBULAR ADVANCEMENT DEVICE

Model Number	1454
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Prosomnus sleep technologies recieved medwatch # mw5176206 directly from the fda/cdrh on (b)(6) 2025; below is the event description re-copied from the report.Prosomnus oral mandibular advancement tray had a piece break off.It is a set of two trays that sit over the teeth and treat sleep apnea by advancing the jaw.
Additional Manufacturer Narrative
On 09-16-2025, prosomnus received a complaint regarding post junction breakage of the subject device.A remake/replacement of the lower arch was shipped on 09-25-2025 under warranty.On 10-14-2025, prosomnus received voluntary medwatch report 5176206 from the fda and subsequently contacted the prescriber's office to obtain further information.No patient harm from post junction breakage was reported in either the medwatch report or the doctor's filled-out investigation form.Visual inspection of the returned device confirmed the breakage of the lower arch's post junction and revealed likely teeth imprints on the occlusal plane, consistent with the markings observed in the doctor's photos.The imprints suggest that the device used incorrectly, and that unforeseen stress and forces were applied to the device itself.The device is designed to be used as a pair, and this type of device misusage would contribute to premature device failure.The doctor confirmed that the device broke during sleep.Although the patient denied bruxism, the imprints indicate significant force during use, supporting bruxism/clenching as a potential contributing factor.Initial performance testing indicates that extreme force, either acute or repetitive, is required to dislodge or break a post junction.Review of the device history records and design files confirmed the device was manufactured per specifications and prescribed configurations.The scans, confirmed accurate by the physician, reveal a mild midline shift to the patient's left, possibly causing rightward lateral pressure on the left post.Even though the midline measurements of these scans remain within out internal acceptable procedural limits, it is very possible that the clinical bit position for this patient may have been inaccurately captured during the scan, contributing to the issue.While multiple potential contributing factors (such as premature device wear, bruxism, and bite discrepancies) are evident, none can be confirmed as the sole cause.Therefore, a definitive root cause cannot be determined.Our device-related risk management report outlines this situation, potential harm, and mitigation strategies for such events, which are within acceptable risk levels.As part of our due diligence, we are reporting this incident in accordance with 21 cfr 803.

• Brand Name: PROSOMNUS EVO SLEEP AND SNORE DEVICE
• Common Device Name: MANDIBULAR ADVANCEMENT DEVICE
• Manufacturer (Section D): PROSOMNUS SLEEP TECHNOLOGIES; 5675 gibraltar drive; pleasanton CA 94588
• Manufacturer (Section G): PROSOMNUS SLEEP TECHNOLOGIES; 5675 gibraltar dr; pleasanton CA 94588
• Manufacturer Contact: divya mavalli ; 5675 gibraltar dr; pleasanton, CA 94588 ; 9253077069
• MDR Report Key: 23514401
• Report Number: 3013116677-2025-00003
• Device Sequence Number: 9955591
• Product Code: LRK
• UDI-Device Identifier: 00863039000485
• UDI-Public: (01)00863039000485(11)250402
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian