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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY SMARTBASE, NARROW; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY SMARTBASE, NARROW; DENTAL IMPLANT Back to Search Results
Catalog Number 8735-80N
Medical Device Problem Code Missing Information (4053)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/04/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This complaint is also for lot 130577 with manufacture date 12/19/2018 and expiration date 12/18/2023.This complaint was identified internally and generated for ncmr (b)(4).Per the ncmr, the part will be destroyed.
 
Event or Problem Description
Per complaint (b)(4), during an internal review, a part was identified as missing a label.
 
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Brand Name
LEGACY SMARTBASE, NARROW
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key9873308
Report Number3001617766-2020-02954
Device Sequence Number560885
Product Code NHA
UDI-Device Identifier10841307122739
UDI-Public10841307122739
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 03/24/2020
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 Date05/06/2024
Device Catalogue Number8735-80N
Device Lot Number139553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/04/2019
Initial Report FDA Received Date03/24/2020
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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