MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS SNAP SCAN BODY

Model Number PBSSB

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

There was one malfunction event reported with the abutment not being able to seat properly and experiencing stability issues during usage.Product was not returned for investigation.Because no product was returned for investigation and no other details were provided, no conclusion can be drawn to the reported issue.No physical evaluation was performed due to product not being returned.The root cause is unable to determine.(b)(4).

Event Description

This report provides a summary of one (1) malfunction event.A review of the event involved the reported abutment(s) not being able to seat properly and having stability issues during usage.No patient adverse event was reported.No information regarding patient demographics have been provided.

• Brand Name: BIOHORIZONS SNAP SCAN BODY
• Type of Device: SCAN BODY
• 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: 15136431
• MDR Text Key: 297049434
• Report Number: 1060818-2022-09395
• Device Sequence Number: 1
• Product Code: NDP
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PBSSB
• Device Catalogue Number: PBSSB
• Device Lot Number: 2103562
• Is the Reporter a Health Professional?: Yes
• 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