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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 924810
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/19/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss or failure of implant to integrate.
 
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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 Key10927857
Report Number3001617766-2020-08354
Device Sequence Number14506755
Product Code DZE
UDI-Device Identifier10841307106203
UDI-Public10841307106203
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K081396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 12/01/2020
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 Date03/31/2021
Device Catalogue Number924810
Device Lot Number75904
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/20/2020
Initial Report FDA Received Date12/01/2020
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;
Patient Age71 YR
Patient Weight73
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