MAUDE Adverse Event Report: OSSEOFUSE INTERNATIONAL INC. DENTAL ABUTMENT; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

During an fda inspection on 11/04/2019, an observation was made on form fda-483 that we were aware of incident involving a customer.The customer called to order a dental implant with abutment initially.Customer mentioned she needed another implant/abutment since a previous abutment screw, that comes with the abutment, had sheared off due to over tightening.Customer had already removed the entire implant prior to ordering.Indicated in the restoration guide, there are specific torque parameters to follow and that removing the entire implant was unnecessary since there are relatively simple ways, that are not unique to our implant system, to remove the sheared off abutment screw within the abutment.We are unaware of the type of abutment used.Before this incident, we had passed on one other complaint involving the abutment screw breaking.Our contact mfr analyzed the issue and determined that the abutment screw had been over tightened which caused the break.This is not a mfg issue.Fda safety report id# (b)(4).

• Brand Name: DENTAL ABUTMENT
• Type of Device: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): OSSEOFUSE INTERNATIONAL INC. ; las vegas NV 89146
• MDR Report Key: 9596144
• MDR Text Key: 175701182
• Report Number: MW5092286
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/13/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention