MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS ABUTMENT; DENTAL ABUTMENT

Model Number DENTAL ABUTMENT

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

There is one (1) malfunctioned units/events associated with a fractured collar.A review of the device history record is performed for any reported event with a valid and confirmed lot number.No nonconformances were noted.Therefore, the conclusion of the device records review concluded the product was manufactured to specifications.The complete device was not returned.The evaluation was performed on various pieces of the device.Because the device was returned in pieces, the root cause that contributed to the failure could not be determined.

Event Description

This report is a summary of one (1) malfunction event.A review of the event involved component device having a fractured collar.No adverse event patient information was reported.No information regarding patient demographics have been provided.

• Brand Name: BIOHORIZONS ABUTMENT
• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 15704431
• MDR Text Key: 304173301
• Report Number: 1060818-2022-13579
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DENTAL ABUTMENT
• Device Catalogue Number: DENTAL ABUTMENT
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1