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

Model Number	RC4110C
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Implant failed due to failure to osseointegrate.

• Brand Name: REFLECT PRECISE
• 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: indie bernardo ; 145 cedar lane; suite 205; englewood, NJ 07631 ; 8662775662
• MDR Report Key: 19291535
• Report Number: 3010730876-2024-00048
• Device Sequence Number: 15236377
• Product Code: DZE
• UDI-Device Identifier: 00817773022074
• UDI-Public: 00817773022074
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/08/2024

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: RC4110C
• Device Lot Number: 161215A0300-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/10/2024
• 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: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White