MAUDE Adverse Event Report: OSSEOFUSE INTERNATIONAL INC OSSEOFUSE INYTERNATIONAL INC; ABUTMENT SCREW WITHIN THE ABUTMENT

Model Number UNKNOWN

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

During an fda inspection on 11/4/2019, an observation was made on form (b)(4) 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 contract manufacturer analyzed the issue and determined that the abutment screw had been over tightened which caused the break.

• Brand Name: OSSEOFUSE INYTERNATIONAL INC
• Type of Device: ABUTMENT SCREW WITHIN THE ABUTMENT
• Manufacturer (Section D): OSSEOFUSE INTERNATIONAL INC; 6170 west desert inn rd; suite b; las vegas NV 89146
• MDR Report Key: 9607147
• MDR Text Key: 221028939
• Report Number: 3008494722-2020-00001
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2020
• Event Location: Outpatient Treatment Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention