MAUDE Adverse Event Report: Biotech Dental Reflect Rapid; Dental Implant

Model Number	RA5010C
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury

• Brand Name: Reflect Rapid
• Common Device Name: Dental Implant
• Manufacturer (Section D): Biotech Dental; 145 cedar lane; suite 205; NJ 07631
• Manufacturer (Section G): Biotech Dental; 145 cedar lane; suite 205; NJ 07631
• Manufacturer Contact: indie bernardo ; 145 cedar lane; suite 205
• MDR Report Key: 50240554
• Report Number: 3010730876-2026-00021
• Device Sequence Number: 10374067
• Product Code: DZE
• UDI-Device Identifier: 00817773024122
• UDI-Public: (01)00817773024122(10)RA000038
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 08/13/2026

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: RA5010C
• Device Lot Number: RA000038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/13/2026
• 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: 61 YR
• Patient Sex: Male
• Patient Race: White