MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS

Model Number SCS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There was one (1) malfunction event associated with this report.No product was returned for investigation.However, the device history record was reviewed and noted no nonconformances.Therefore, the conclusion is that the item was manufactured to specifications.Because no product was returned for investigation, no conclusion may be drawn that the product malfunctioned in the field.The units involved in this report are: item: igold clinical retaining screw, qty: 1.

Event Description

This report indicates one (1) malfunction event.A review of the event involved a broken abutment screw.No patient consequence was noted for the one (1) event.No information regarding the demographic of the patient was provided.

• Brand Name: BIOHORIZONS HEX ABUTMENTS
• Type of Device: HEX ABUTMENTS
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham, al
• Manufacturer (Section G): INTRA-LOCK INTERNATIONAL, INC.; 2300 riverchase center; suite 815; birmingham, al
• Manufacturer Contact: anissa smith ; 2300 riverchase center; suite 815; birmingham, al
• MDR Report Key: 10353525
• MDR Text Key: 202520694
• Report Number: 3003631996-2020-00199
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SCS
• Device Catalogue Number: SCS
• Type of Device Usage: N
• Patient Sequence Number: 1