MAUDE Adverse Event Report: BIOTECH DENTAL REFLECT RAPID; DENTAL IMPLANT

Model Number	RA5011C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Implant failed due to fracture.

• Brand Name: REFLECT RAPID
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOTECH DENTAL; 145 cedar lane; suite 205; englewood NJ 07631
• Manufacturer (Section G): BIOTECH DENTAL; 145 cedar lane; suite 205; englewood NJ 07631
• Manufacturer Contact: joanne bernardo ; 145 cedar lane; suite 205; englewood, NJ 07631 ; 8662775662
• MDR Report Key: 18753593
• Report Number: 3010730876-2024-00013
• Device Sequence Number: 17078998
• Product Code: DZE
• UDI-Device Identifier: 00817773024139
• UDI-Public: 00817773024139
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K180924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RA5011C
• Device Lot Number: 181106A1250-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic