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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 934808
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event 09/05/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The complaint indicated that the device was a tool and was initially evaluated as not reportable.The complaint proceeded through the closure process.On (b)(6) 2019, during a retrospective review of complaints, this complaint was identified as having a part number update and has since been re-opened and re-evaluated for reportability.Since initial closure of complaint, procedure updates have been made to make note of real time changes.
 
Event or Problem Description
Per complaint (b)(4), a patient experienced pain and bone loss due to implant stability loss.The implant was removed.
 
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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 Key9236785
Report Number3001617766-2019-02314
Device Sequence Number13846120
Product Code DZE
UDI-Device Identifier10841307106456
UDI-Public10841307106456
Combination Product (Y/N)N
Initial Reporter StateID
Initial Reporter CountryUS
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 10/17/2019
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 Number934808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/17/2019
Initial Report FDA Received Date10/25/2019
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 Age46 YR
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