Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWISHPLUS IMPLANT; DENTAL IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SWISHPLUS IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 924112
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/19/2021
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 laboratory procedure, patient experienced loss or failure of implant to integrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SWISHPLUS IMPLANT
Common Device Name
DENTAL IMPLANT
MDR Report Key12681835
Report Number3001617766-2021-06195
Device Sequence Number13794040
Product Code DZE
UDI-Device Identifier10841307106159
UDI-Public10841307106159
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 Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 11/03/2021
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 Date03/08/2022
Device Catalogue Number924112
Device Lot Number91410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Initial Date Received by Manufacturer 10/14/2021
Supplement Date Received by Manufacturer10/14/2021
Initial Report FDA Received Date10/22/2021
Supplement Report FDA Received Date11/03/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured03/09/2017
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 Age24 YR
-
-