MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZON INTERNAL 4.5MM BULK PREP ABUTMENT; BULK PREP ABUTMENT - 4.5MM

Model Number PGBPA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned from customer as of today.Therefore, no evaluation can take place.

Event Description

The abutment hex failed.

• Brand Name: BIOHORIZON INTERNAL 4.5MM BULK PREP ABUTMENT
• Type of Device: BULK PREP ABUTMENT - 4.5MM
• Manufacturer (Section D): BIOHORIZONS, INC.; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244 ; 2059867888
• MDR Report Key: 7341844
• MDR Text Key: 102874015
• Report Number: 1060818-2018-00004
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/08/2018

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: Other
• Device Model Number: PGBPA
• Device Catalogue Number: PGBPA
• Device Lot Number: 1601817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1