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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 603516
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 09/05/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Information was not provided and if it becomes available, a follow-up report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), patient experienced failure of implant to integrate.
 
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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 91362
MDR Report Key9625329
Report Number3001617766-2020-00781
Device Sequence Number14049181
Product Code DZE
UDI-Device Identifier10841307104025
UDI-Public10841307104025
Combination Product (Y/N)N
Initial Reporter CountrySP
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 distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 05/07/2020
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 Date12/07/2022
Device Model Number603516
Device Catalogue Number603516
Device Lot Number105582
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 09/16/2019
Supplement Date Received by Manufacturer03/02/2020
Initial Report FDA Received Date01/24/2020
Supplement Report FDA Received Date05/07/2020
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;
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