PHILIPS RESPIRONICS SYSTEM ONE /REMSTAR PRO C/FLAP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for PHILIPS RESPIRONICS SYSTEM ONE /REMSTAR PRO C/FLAP manufactured by Philips Respironics, Inc..

Event Text Entries

[102008632] To begin with, i wore braces as a teenager (as many teens do), orthodontic retainers every night, and had straight teeth for many years of my adult life. In approximately 2006, i had elective jaw surgery to advance my chin and lower jaw. The results were successful: my teeth remained straight, and i had no jaw pain or jaw problems after the surgery. In 2009, i was diagnosed with sleep apnea. The respiratory therapist recommended a full face mask cpap device; i have used same virtually every night since then, and continue to do so now. Within a year of using the face mask, i noticed that i was no longer fitting into my orthodontic retainers (which had previously fit perfectly for many years). I therefore went to see my orthodontist: special retainers were made, in an attempt to realign/correct my bite. Unfortunately, the retainers were unsuccessful in doing so. Orthodontist then put me back into braces. Despite the braces, my bite kept shifting. This was puzzling to the orthodontist. Orthodontist and i noticed that the skin on the right side of my face was pulling down. Also, i had difficulty putting my lips together. Because my bite was uncomfortable orthodontically, and i had facial soft tissue shifting, the orthodontist said that i would need a second jaw surgery. The second jaw surgery was performed in 2013. The oral surgeon instructed me to continue my sleep apnea treatment/using my face mask, after surgery, which i did. When my jaw was unwired several weeks later, i noticed that i had difficulty closing my mouth. Also, there was mild tmj clicking/noises. The oral surgeon said that i had a shifting problem, and was puzzled as to why. I then went to the orthodontist for post-surgical orthodontic work. As part of this treatment, elastics were used. The elastics caused extreme pain, and had to be discontinued (i had been in elastics before, and had only experienced mild discomfort; never extreme pain). At the end of this orthodontic treatment, my teeth were straight, but only very briefly. Soon thereafter, my teeth shifted and then my bite began to open up. This occurred even though the braces were still holding everything in place. The orthodontist was very puzzled, and felt that it was probably due to the medical device interfering with the result (but this was not well-known at the time). I tried to get answers; other opinions as to what was causing this problem. This included: 2 separate full rounds of physical therapy; neither round of treatment was helpful. I saw several doctors at both (b)(6) hospital, and (b)(6) in (b)(6). Two of these doctors did state that sleep apnea/cpap devices cause dental and facial shifting problems. Another dentist in (b)(6), and my orthodontist (as already mentioned) also stated that dental and facial shifting problems can occur from sleep apnea/cpap devices. It is important to note that, in many cases, i had to wait several months to obtain appointments with many of these doctors, due to their busy schedules. This caused time lapses beyond my control. I am presently left with jaw and tmj pain, as well as an open bite/ i cannot close my mouth. This causes problems chewing food, and other related issues. I was even recently hospitalized for jaw pain. My teeth are also misaligned. My appearance is adversely affected. I was told by another maxillofacial surgeon (at (b)(6) hospital) that orthodontics alone cannot correct my bite; i would need a third surgery (with all of the possible surgical risks thereof), plus new orthodontics all over again (very costly) to try to correct this situation. This would greatly increase the financial strain already in place from the various doctor's appointments and physical therapy, thus far. This has not only been a physical strain for me, but a financial and emotional strain for me and my family. The situation remains unresolved. In summary, there is good evidence for the sleep apnea/cpap devices causing the problems that i have, and do experience. I had a good first surgical outcome, and was fine until after i started sleep apnea treatment in 2009. The shifting problem occurred a second time, in 2014, after the second jaw surgery. Therefore, the cpap device undid all of the surgical and orthodontic work, times two. Four doctors have indicated that sleep apnea/cpap devices can cause shifting problems. I am therefore asking the fda to intervene on my behalf, including seeking financial compensation from the cpap manufacturer. Teeth and jaw shifting problems, with pain. Problems chewing and closing mouth, with tmj pain. The problem occurred from chronic, regular use of the cpap device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075620
MDR Report Key7312972
Date Received2018-03-01
Date of Report2018-02-19
Date of Event2010-01-01
Date Added to Maude2018-03-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NamePHILIPS RESPIRONICS SYSTEM ONE /REMSTAR PRO C/FLAP
Generic NameCPAP DEVICE
Product CodeBYE
Date Received2018-03-01
ID NumberREF #DS6HFLG
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerPHILIPS RESPIRONICS, INC.

Device Sequence Number: 1

Brand NamePHILIPS RESPIRONICS SYSTEM ONE /REMSTAR PRO C/FLAP
Generic NameCPAP DEVICE
Product CodeBYE
Date Received2018-03-01
ID NumberREF #DS6HFLG
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS RESPIRONICS

Device Sequence Number: 2

Brand NameCPAP
Generic NameCPAP DEVICE
Product CodeBYE
Date Received2018-03-01
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerRESMED


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention; 3. Deathisabilit 2018-03-01

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