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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHACTIVE IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 944810
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/09/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's identifier, weight and implant date were not provided.When the requested information becomes available, a supplementary report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced failure of implant to integrate.
 
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Brand Name
SWISHACTIVE IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key11848580
Report Number3001617766-2021-02807
Device Sequence Number3746978
Product Code DZE
UDI-Device Identifier10841307106722
UDI-Public10841307106722
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K130572
Number of Events Summarized1
Summary Report (Y/N)N
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) 05/19/2021
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 Date03/17/2025
Device Catalogue Number944810
Device Lot Number162724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/23/2021
Initial Report FDA Received Date05/19/2021
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 Age61 YR
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