MAUDE Adverse Event Report: OASYS SLEEP--DR. MARK ABRAMSON O2 OASYS ORAL/NASAL AIRWAY SYSTEM; DEVICE, ANTI-SNORING

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Date 05/03/2021

Event Type  Injury  

Event Description

The oasys oral/nasal airway system, a mandibular advance device for mild obstructive sleep apnea, was prescribed to me in (b)(6) 2012.I have worn it nightly since then, but now i have a severe underbite, crooked teeth, and had to have a dental implant in 2020, all of which are attributable to use of this device.The product literature that i received did not talk about these issues, nor does the website, or as near as i can tell, the fda 510k filing.I visited an orthodontist last week and she is recommending 18-24 months of invisalign, with rubber bands, to correct these issues.I am (b)(6) years old and have never had malocclusion problems or crooked teeth.I have no other implants other than the one i had last year, to replace a front tooth that broke off at the gumline.I am very unhappy and believe that had the prescribing dentist more closely monitored me, he may have seen the misalignment in the earliest stages and many of the problems could have been mitigated.At the very minimum, it should be made clear in the product literature that malocclusion is a potential side effect and that patients should be monitored on a regular basis.Fda safety report id # (b)(4).

• Brand Name: O2 OASYS ORAL/NASAL AIRWAY SYSTEM
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): OASYS SLEEP--DR. MARK ABRAMSON; 35 renato court ; redwood city CA 94061
• MDR Report Key: 11847927
• MDR Text Key: 251734185
• Report Number: MW5101411
• Device Sequence Number: 1
• Product Code: LRK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 102