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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHTAPERED IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHTAPERED IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 934806
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/31/2018
Type of Reportable Event Malfunction
Event or Problem Description
Per complaint (b)(4), during the clinical procedure, implants could not achieve primary stability.They were replaced with a wider implant, but the implant used became stuck within the placement instrument.The implant was extracted as a result.
 
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Brand Name
SWISHTAPERED IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8553640
Report Number3001617766-2019-00188
Device Sequence Number19642423
Product Code DZE
UDI-Device Identifier10841307106449
UDI-Public10841307106449
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/10/2021
Device Catalogue Number934806
Device Lot Number75219
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/01/2018
Initial Report FDA Received Date04/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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