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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
Catalog Number 923310
Medical Device Problem Code Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event 08/06/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient reported pain associated with their dental implant.The patient was brought in to dentist to look.The implant was removed on a different date.Bone loss was also reported.
 
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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 Key8091578
Report Number3001617766-2018-00329
Device Sequence Number1279620
Product Code DZE
UDI-Device Identifier10841307106081
UDI-Public10841307106081
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K090234
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
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 11/20/2018
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 Date04/14/2021
Device Catalogue Number923310
Device Lot Number76645
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/24/2018
Initial Report FDA Received Date11/20/2018
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 Age41 YR
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