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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 944808
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 11/03/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lot information is unknown.If additional information becomes available a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), after clinical procedure, components could not be separated.
 
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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 Key10981582
Report Number3001617766-2020-08668
Device Sequence Number2699855
Product Code DZE
UDI-Device Identifier10841307106715
UDI-Public10841307106715
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 Implanted Year2020
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) 12/09/2020
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 Catalogue Number944808
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/11/2020
Initial Report FDA Received Date12/10/2020
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 Age52 YR
Patient Weight73
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