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

Model Number PXMUAS

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This report provides a summary of one (1) malfunction event.A review of the event involved the reported abutment screw stripped during usage.No patient adverse event was reported.No information regarding patient demographics have been provided.

Manufacturer Narrative

There was one malfunction event reported with the abutment screw stripping during usage.No physical evaluation was performed due to product not being returned.Because no product was returned for evaluation and no other details were provided, no conclusion can be drawn to the reported issue.Therefore, root cause was concluded unable to determine.(b)(4).

• Brand Name: BIOHORIZONS ABUTMENT SCREW
• Type of Device: MULTI-UNIT ABUTMENT SCREW
• 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: 15705048
• MDR Text Key: 302769823
• Report Number: 1060818-2022-13576
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00847236006532
• UDI-Public: 00847236006532
• 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: PXMUAS
• Device Catalogue Number: PXMUAS
• Device Lot Number: PO21030262
• 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