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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 606011
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 11/04/2019
Type of Reportable Event Serious Injury
Event or Problem Description
As per complaint (b)(4), during a clinical procedure, a patient presented a dental implant that displayed an osseointegration problem and the implant was explanted.No patient impact was recorded.
 
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Brand Name
REPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key9757647
Report Number3001617766-2020-00583
Device Sequence Number2456861
Product Code DZE
UDI-Device Identifier10841307104155
UDI-Public10841307104155
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K061319
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
Report Date (Section B) 02/26/2020
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 Date01/31/2024
Device Model Number606011
Device Catalogue Number606011
Device Lot Number132876
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/07/2020
Initial Report FDA Received Date02/26/2020
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 Age71 YR
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