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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY REPLANT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY REPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 603511U
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced failure of implant to integrate.
 
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Brand Name
SIMPLY REPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key10874488
Report Number3001617766-2020-08126
Device Sequence Number3316242
Product Code DZE
UDI-Device Identifier10841307108252
UDI-Public10841307108252
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 11/20/2020
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 Date11/14/2023
Device Catalogue Number603511U
Device Lot Number128396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/29/2020
Initial Report FDA Received Date11/20/2020
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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