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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY INTERACTIVE IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY INTERACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 655016U
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Sinus Perforation (2277); Osteopenia/ Osteoporosis (2651)
Date of Event 12/12/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), a dental implant was placed too far into a patient's sinus.The implant was immediately extracted.Osteopenia was also reported, and bone grafting was performed.The procedure was not completed within the same visit.
 
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Brand Name
SIMPLY INTERACTIVE IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8620371
Report Number3001617766-2019-00228
Device Sequence Number263263
Product Code DZE
UDI-Device Identifier10841307107026
UDI-Public10841307107026
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K130572
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 05/17/2019
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 Expiration Date04/28/2021
Device Catalogue Number655016U
Device Lot Number77648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/18/2019
Initial Report FDA Received Date05/17/2019
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;
Patient Age65 YR
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