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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 704710
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event 10/04/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), patient experienced lack of primary stability.
 
Additional Manufacturer Narrative
Section a4 for the patient's weight is unknown.
 
Additional Manufacturer Narrative
Followup report sent to state that the medical device was not received for analysis.
 
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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 91362
MDR Report Key9097619
Report Number3001617766-2019-03872
Device Sequence Number11427154
Product Code DZE
UDI-Device Identifier10841307104292
UDI-Public10841307104292
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K073161
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup,Followup
Report Date (Section B) 06/04/2020
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 Date07/25/2020
Device Model Number704710
Device Catalogue Number704710
Device Lot Number66438
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/26/2019
Supplement Date Received by Manufacturer12/23/2019
12/23/2019
Initial Report FDA Received Date09/20/2019
Supplement Report FDA Received Date05/13/2020
06/04/2020
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 Age75 YR
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