MAUDE Adverse Event Report: BIOTECH DENTAL REFLECT RAPID; IMPLANT

Model Number	RA4311C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient n daher received implant (rflt rapid ra4311c reflect rapid fixture ø4.3mm x 11.5 l) on (b)(6) 2021 and experienced a failure to integrate which led to having the implant removed on (b)(6) 2022.X-rays werenot provided by the dentist.Implant replacement was sent to dr.Yudi sugiono on (b)(6) 2022.

• Brand Name: REFLECT 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: 15793651
• Report Number: 3010730876-2022-00097
• Device Sequence Number: 11950682
• Product Code: DZE
• UDI-Device Identifier: 00817773024085
• UDI-Public: 00817773024085
• 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: 2021
• 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): 11/04/2022

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: Health Professional
• Device Model Number: RA4311C
• Device Catalogue Number: RA4311C
• Device Lot Number: 032
• 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: 05/09/2022
• Initial Report FDA Received Date: 11/14/2022
• 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: 60 YR
• Patient Sex: Female