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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 924810W
Medical Device Problem Codes Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 10/23/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), during implant placement, the implant fenestrated the patient lingual plate.The implant was extracted.
 
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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 Key8116812
Report Number3001617766-2018-00346
Device Sequence Number19255614
Product Code DZE
UDI-Device Identifier10841307106258
UDI-Public10841307106258
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K081396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/29/2018
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 Date05/01/2022
Device Model Number924810W
Device Catalogue Number924810W
Device Lot Number93934
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/30/2018
Initial Report FDA Received Date11/29/2018
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 Age39 YR
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