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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWISHPLUS IMPLANT; DENTAL IMPLANT
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SWISHPLUS IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 924812
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/05/2021
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
MDR Report Key12631692
Report Number3001617766-2021-06049
Device Sequence Number4343864
Product Code DZE
UDI-Device Identifier10841307106210
UDI-Public10841307106210
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K081396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
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) 10/14/2021
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 Date02/21/2023
Device Catalogue Number924812
Device Lot Number109831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/08/2021
Initial Report FDA Received Date10/14/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/22/2018
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age35 YR
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