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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHPLUS IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHPLUS IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 924808W
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 11/26/2018
Type of Reportable Event Serious Injury
Event or Problem Description
As per complaint (b)(4), during a clinical procedure a dental implant displayed a failure of osseointegration and was explanted.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated g1-g2 for follow-up report submitter, g7 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status,and h6 method, result and conclusion codes.
 
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Brand Name
SWISHPLUS IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9532535
Report Number3001617766-2019-02278
Device Sequence Number11348230
Product Code DZE
UDI-Device Identifier10841307106241
UDI-Public10841307106241
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 05/20/2020
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 Date02/18/2024
Device Model Number924808W
Device Catalogue Number924808W
Device Lot Number135269
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/02/2019
Supplement Date Received by Manufacturer12/02/2019
Initial Report FDA Received Date12/30/2019
Supplement Report FDA Received Date05/20/2020
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;
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