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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 924112
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 03/22/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption # e2012017, report late due to asr to individual reporting transition.
 
Event or Problem Description
Per complaint (b)(4), the patient experienced failure or loss of implant to integrate and the implant was mobile.
 
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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 Key8986956
Report Number3001617766-2019-02708
Device Sequence Number3046667
Product Code DZE
UDI-Device Identifier10841307106159
UDI-Public10841307106159
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K081396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
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) 09/10/2019
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 Date02/12/2022
Device Catalogue Number924112
Device Lot Number89582
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/24/2019
Initial Report FDA Received Date09/11/2019
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 Age63 YR
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