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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 755708
Medical Device Problem Code Positioning Problem (3009)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 09/06/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), patient experienced lack of primary stability.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.
 
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Brand Name
REACTIVE IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9140125
Report Number3001617766-2019-04235
Device Sequence Number2782556
Product Code DZE
UDI-Device Identifier10841307103738
UDI-Public10841307103738
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K080713
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 10/18/2019
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 Date01/17/2024
Device Catalogue Number755708
Device Lot Number133013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2019
Initial Date Received by Manufacturer 09/10/2019
Supplement Date Received by Manufacturer10/09/2019
Initial Report FDA Received Date10/01/2019
Supplement Report FDA Received Date10/18/2019
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 Age45 YR
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