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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
Catalog Number 924108
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Insufficient Information (4580)
Date of Event 12/14/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's identifier, weight and other relevant history, including preexisting medical conditions were not provided.If the requested information becomes available, a supplementary report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss or failure of implant to integrate.
 
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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 Key12336424
Report Number3001617766-2021-04923
Device Sequence Number2754408
Product Code DZE
UDI-Device Identifier10841307106135
UDI-Public10841307106135
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K081396
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 distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 08/18/2021
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 Date01/11/2025
Device Catalogue Number924108
Device Lot Number158031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/25/2021
Initial Report FDA Received Date08/18/2021
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 Age41 YR
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