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

Model Number	RR4308C
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Implant failed due to failure to osseointegrate.

• Brand Name: REFLECT RECOVER
• 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: 17967282
• Report Number: 3010730876-2023-00057
• Device Sequence Number: 12717925
• Product Code: DZE
• UDI-Device Identifier: 00817773023064
• UDI-Public: 00817773023064
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K180924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/17/2023

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: RR4308C
• Device Lot Number: 210712A2490-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/19/2023
• 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: 51 YR
• Patient Sex: Female