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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE ANGLED OVERDENTURE ABUTMENT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE ANGLED OVERDENTURE ABUTMENT; DENTAL IMPLANT Back to Search Results
Model Number 6534-63-15S
Medical Device Problem Code Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Included na for patient identifier and other relevant history to indicate not applicable.
 
Event or Problem Description
(b)(4), the udi number on the product label was incorrect.This is an internal complaint, there was no patient involvement.
 
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Brand Name
INTERACTIVE ANGLED OVERDENTURE ABUTMENT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key9800311
Report Number3001617766-2020-01906
Device Sequence Number609759
Product Code NHA
UDI-Device Identifier10841307109440
UDI-Public10841307109440
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K130572
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 03/06/2020
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 Expiration Date03/18/2023
Device Model Number6534-63-15S
Device Catalogue Number6534-63-15S
Device Lot Number111810
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/12/2020
Initial Report FDA Received Date03/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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