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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 925710
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 11/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), during laboratory procedure, patient experienced loss or failure of implant to integrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.A1 patient identifier, a4 patient weight, not provided.
 
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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 Key9626644
Report Number3001617766-2020-00941
Device Sequence Number11429012
Product Code DZE
UDI-Device Identifier10841307106302
UDI-Public10841307106302
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K081396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 05/21/2020
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 Date07/21/2021
Device Model Number925710
Device Catalogue Number925710
Device Lot Number81096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2020
Initial Date Received by Manufacturer 11/20/2019
Supplement Date Received by Manufacturer11/20/2019
Initial Report FDA Received Date01/24/2020
Supplement Report FDA Received Date05/21/2020
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 Age55 YR
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