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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTECH DENTAL REFLECT PRECISE; DENTAL IMPLANT
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BIOTECH DENTAL REFLECT PRECISE; DENTAL IMPLANT Back to Search Results
Model Number RC5013C
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/18/2024
Type of Reportable Event Malfunction
Event or Problem Description
Implant failed due to failure to osseointegrate.
 
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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 Key20905146
Report Number3010730876-2024-00143
Device Sequence Number18413820
Product Code DZE
UDI-Device Identifier00817773022142
UDI-Public00817773022142
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K180924
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
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) 12/11/2024
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 NumberRC5013C
Device Lot Number161215A0240-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/11/2024
Was Device Evaluated by Manufacturer? (Y/N) No
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 Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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