MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS ABUTMENT

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is to provides a summary of five (5) malfunction events related to an abutment experiencing a connection or engagement issues.A lot number device history record review could not take place on either of the events due to no lot number was reported.2 of the devices were evaluated and determined to be misuse by the end user during usage.The returned hex of the devices contained biological/surgical debris.Improper technique or improper use of the product was determined to be the failure cause.The root cause concluded use error.3 of the devices were evaluated and the failure cause could not be determined.Product was not returned for either of the three devices reported.Hence, a product evaluation did not take place.No valid item number nor lot number was reported during the complaint intake.So, the udi number could not be listed.

Event Description

This report summarizes five (5) malfunction events.A review of the events involved an abutment experiencing connection/engagement issues.Zero (0) patient adverse events were reported.No information regarding patient demographics have been provided.

Manufacturer Narrative

This report is to provides a summary of five (5) malfunction events related to an abutment experiencing a connection or engagement issues.A lot number device history record review could not take place on either of the events due to no lot number was reported.2 of the devices were evaluated and determined to be misuse by the end user during usage.The returned hex of the devices contained biological/surgical debris.Improper technique or improper use of the product was determined to be the failure cause.The root cause concluded use error.3 of the devices were evaluated and the failure cause could not be determined.Product was not returned for either of the three devices reported.Hence, a product evaluation did not take place.No valid item number nor lot number was reported during the complaint intake.So, the udi number could not be listed.Follow up #1: 2 of the 5 units involved are item numbers" - pymu303 (udi: (b)(4)) 3 of the 5 were units with unknown item.Therefore, no udi number can not be determined.

Event Description

This report summarizes five (5) malfunction events.A review of the events involved an abutment experiencing connection/engagement issues.Zero (0) patient adverse events were reported.No information regarding patient demographics have been provided.

• Brand Name: BIOHORIZONS ABUTMENT
• Type of Device: BIOHORIZONS 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: 15705185
• MDR Text Key: 302771309
• Report Number: 1060818-2022-13569
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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