FIXED EXPANDER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-13 for FIXED EXPANDER * manufactured by Allesee Orthodontic Expander.

Event Text Entries

[17038332] In 2006, i received a defective palette expander that failed to expand my palette, resulted in a serious injury by carving out the left side of my palette and forced me to stop the orthodontic treatment plan. Six months previously, i met with dmd for an initial consultation. During that meeting, dr outlined the orthodontic treatment plan, which included getting measured for a palette expander. She estimated that i would wear for about six months. Dr and her staff prepared the records and cast the mold. Dr placed the palette expander in my mouth. A month later, i met with dr who instructed me to begin cranking the palette expander once a day. She expressed concern that it did not appear to expand enough and stated that if i did not noticeably feel the device moving, then it probably was not turning properly. The next day, when i turned the key, i did not feel the device expanding so i made an appointment to see dr at her earliest convenience, which was 19 days later at 4:30 p. M. I continued to turn the key daily. On the evening of 17 days later, after turning the key, suddenly felt a tremendous amount of pain, which did not abate. The next day, i called dr's office to see i would be able to schedule an earlier appointment, but dr was out of town. I visited my primary care physician who prescribed naproxen and was unable to go to work. I went to work, but was forced to leave after one hour because of the pain. Soon thereafter, i went to dr's office, and she cut away a portion of the acrylic, which relieved the most excruciating pain of my life by fifty percent, but still left a tremendous amount of pain, which did not abate. Dr instructed me to wait a week before removing the palette expander. We were reluctant to remove the palette expander because it would reverse any progress made up to that point. The next day, i admitted that the pain medication was not working. Dr does not have a dea number so my primary care physician prescribed acetaminophen, which i could only take at night. Every day, until the palette expander was removed, i was taking more than the recommended amount of ibuprofen and naproxen. I could not sleep and could barely focus at work. Three days later, before i went to bed, i noticed that the gums on the left side began to turn white so 2 days later, i visited the emergency room of medical center. Another dmd, stated that i was not suffering from necrosis, but circulation was cut off, and the palette expander needed to be removed as soon as possible. He prescribed penicillin. Two days later, i called my dr's office, but was unable to schedule an earlier appointment. The next day, the appliance was removed. -having the appliance removed was more painful than when i had my wisdom teeth removed or anything that i hope to endure in my life. - i was finally able to see what was going on underneath the palette expander and what caused so much pain. The entire left side of my palette was scooped away as if a melon scooper was used on it. There was a lot of blood loss, but it was not critical. The next day, dr gave me a prescription for penicillin. As a result, i was unable to eat on the left side of my mouth, and probably used the right side of my mouth too much. As a result, there was a tiny cut on the bottom right gum, which i asked my dentist, to check. He was tremendously alarmed by the left side of my palette and stated that the palette expander was probably defective and was not supposed to function that way. My dentist gave me a perscription for penicillin because the left side of my palette was still exposed and raw, which could have led to infection. Six days later, i met with dr, terminated her services, and discussed the situation. We discussed the possibility of overcranking, but when she measured the palette expander, she said that it was at the right length for the amount of time that i was cranking it. The next month, i had my annual checkup with my dentist, and by then, my palette had improved. Two months later, the cement residue from the palette expander was removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1042875
MDR Report Key853059
Date Received2007-05-13
Date of Report2007-05-13
Date of Event2006-10-29
Date Added to Maude2007-05-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFIXED EXPANDER
Generic NamePALETTE EXPANDER
Product CodeDYJ
Date Received2007-05-13
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key839085
ManufacturerALLESEE ORTHODONTIC EXPANDER
Manufacturer Address* STURTEVANT WI 53177 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-05-13

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