MAUDE Adverse Event Report: BIOTECH DENTAL REFELCT RAPID; IMPLANT

Model Number	RA5011C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient (b)(6) received implant on (b)(6) 2022 and experience a failure to integrate on (b)(6) 2022 as reported by dr.(b)(6) of (b)(6) dental.The implant was the rflt rapid ra5011c reflect rapid fixture ø5.0mm x 11.5 l (s/n (b)(4)).Implant was exchanged for the same size.

• Brand Name: REFELCT RAPID
• Common Device Name: 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: chris castellano ; 145 cedar lane; suite 205; englewood, NJ 07631 ; 8662775662
• MDR Report Key: 15872974
• Report Number: 3010730876-2022-00036
• Device Sequence Number: 2505628
• Product Code: DZE
• UDI-Device Identifier: 00817773024139
• UDI-Public: 00817773024139
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K180924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RA5011C
• Device Catalogue Number: RA5011C
• Device Lot Number: 004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 11/28/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Female