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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT IMPLANT; DENTAL IMPANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT IMPLANT; DENTAL IMPANT Back to Search Results
Catalog Number 604316
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Numbness (2415)
Date of Event 07/09/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), it was discovered during clinical procedure that a patient experienced numbness in their mouth.Their dental implant had to be removed immediately.The implant was removed a week after placement.
 
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Brand Name
REPLANT IMPLANT
Common Device Name
DENTAL IMPANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest dr.
thousand oaks CA 91362
MDR Report Key8700393
Report Number3001617766-2019-00279
Device Sequence Number11413137
Product Code DZE
UDI-Device Identifier10841307104070
UDI-Public10841307104070
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 05/11/2019
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 Date01/08/2022
Device Catalogue Number604316
Device Lot Number85410
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/16/2019
Initial Report FDA Received Date06/14/2019
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 Age49 YR
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