MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS ODSECURE ABUTMENT INTERNAL KIT; ODSECURE ABUTMENT INTERNAL KIT, 4.5 PLATFORM

Model Number PGODSK3

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The medical device evaluation concluded no defects were identified as a result of the manufacturng process.The returned device was manufactured to all specifications.The abutment was tested with an ivt housing cap and sert.The returned abutment passed.The evaluation concluded product functioned as designed.

Event Description

The retentive cap wasn't holding properly.

• Brand Name: BIOHORIZONS ODSECURE ABUTMENT INTERNAL KIT
• Type of Device: ODSECURE ABUTMENT INTERNAL KIT, 4.5 PLATFORM
• Manufacturer (Section D): BIOHORIZONS, INC.; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS, INC.; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 7439588
• MDR Text Key: 106015491
• Report Number: 1060818-2018-00017
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: PGODSK3
• Device Catalogue Number: PGODSK3
• Device Lot Number: 1701715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1