MAUDE Adverse Event Report: RANIR, LLC GRIND NO MORE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Tooth Fracture (2428)

Event Date 12/30/2011

Event Type  Injury  

Event Description

Consumer said that the product "must have shifted in my mouth enough so that one of my teeth, tooth number 12, cracked at the root.".

Manufacturer Narrative

Consumer submitted a proposed treatment plan, which did not include any assessment of the cause of the damage by the dentist.Consumer also stated that there was nothing that indicated that there was any defect with the bruxism device.This is an over the counter bruxism device intended for mild to moderate bruxism.Consumer stated that she normally uses a prescription device, which is intended for extreme bruxing, but used this device because she forgot her prescription device.Labeling clearly states that the device should not be used if it dislodges easily.The device was not returned, so a complete evaluation could not be completed.This report is being submitted as a cracked tooth is considered a serious injury.Medical attention was sought.Note: this report is being provided as a part of a retrospective review, per discussion with fda medical device policy branch, and was performed as a result of recent changes/improvements made to our mdr reporting system as a result of an internal audit.This resulted in a two-year retrospective review for reportable events in order to identify and submit all events meeting the criteria described by the fda representative.

• Brand Name: GRIND NO MORE
• Manufacturer (Section D): RANIR, LLC; 4701 east paris ave. s.e.; grand rapids MI 49512
• Manufacturer Contact: 4701 east paris ave. s.e.; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 3565380
• MDR Text Key: 18858118
• Report Number: 1825660-2013-00014
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention