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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLUS IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLUS IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 705708
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event 01/01/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced failure of implant to osseointegrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Information for section a4 was not available.When information becomes available, a supplemental report will be filed.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.
 
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Brand Name
REPLUS IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key9791927
Report Number3001617766-2020-02118
Device Sequence Number14149821
Product Code DZE
UDI-Device Identifier10841307104339
UDI-Public10841307104339
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K073161
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
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) 11/05/2020
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 Date01/20/2021
Device Model Number705708
Device Catalogue Number705708
Device Lot Number73464
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2020
Initial Date Received by Manufacturer 02/21/2020
Supplement Date Received by Manufacturer07/17/2020
Initial Report FDA Received Date03/05/2020
Supplement Report FDA Received Date11/05/2020
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;
Patient Age65 YR
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