MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS MULTI-UNIT STRAIGHT ABUTMENT; MULTI-UNIT ABUTMENT

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This report summarizes two (2) malfunction events.A review of the events involved an abutment that would fit into corresponding implant or accessories.The report was received from various sources.No patient adverse events were reported.No information regarding patient demographics was provided.

Manufacturer Narrative

There were two (2) malfunction events reported.There were two (2) malfunction events reported.The product was not returned for either of the two events.Therefore, no physical evaluation of the product has occurred.Because no product has been returned no conclusion may be drawn impacting the product.No nonconformances were documented within the production records.The conclusion is that the product was manufactured to specification.Devices involved: 3.0mm direct pickup coping, long, hexed.Internal 3.5mm regular direct pick-up coping, hexed.(b)(4).

• Brand Name: BIOHORIZONS MULTI-UNIT STRAIGHT ABUTMENT
• Type of Device: MULTI-UNIT 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: 14289850
• MDR Text Key: 293349775
• Report Number: 1060818-2022-05035
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2022

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1