MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING, LLC GPS BAR 4-6 IMPLANTS; OVERDENTURE BAR

Model Number 1000-69-ODG

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

Device still have not been returned.

Event Description

The device, an over-denture bar broke in the patient's mouth.When the device broke, it cut the patient's gingiva.The device broke during mastication.The patient came back to the dentist's office and was examined and the dentist performed a visual inspection.The dentist then proceeded to remove the broken device.The patient has fully recovered and is awaiting on a new bar.

• Brand Name: GPS BAR 4-6 IMPLANTS
• Type of Device: OVERDENTURE BAR
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING, LLC; 3050 e. hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING, LLC; 3050 e. hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: terrance abid ; 3050 e. hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 6143439
• MDR Text Key: 61395434
• Report Number: 3001617766-2016-00004
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 1000-69-ODG
• Device Catalogue Number: 1000-69-ODG
• Device Lot Number: 77488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR