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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHPLANT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 904808
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event 04/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation (b)(4).
 
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to osseointegration.
 
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Brand Name
SWISHPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key10535031
Report Number3001617766-2020-06299
Device Sequence Number373161
Product Code DZE
UDI-Device Identifier10841307105930
UDI-Public10841307105930
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 Year2011
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) 09/15/2020
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 Date02/19/2014
Device Catalogue Number904808
Device Lot Number20861
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/23/2020
Initial Report FDA Received Date09/15/2020
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 Age64 YR
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