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: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHACTIVE 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
 

IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 944808
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Wound Dehiscence (1154); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event 04/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's weight is unknown.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).
 
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced loss of implant to osseointegrate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SWISHACTIVE IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key11824460
Report Number3001617766-2021-02588
Device Sequence Number19097927
Product Code DZE
UDI-Device Identifier10841307106715
UDI-Public10841307106715
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K130572
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 05/14/2021
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 Date03/03/2024
Device Catalogue Number944808
Device Lot Number134928
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/14/2021
Initial Report FDA Received Date05/14/2021
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 Age62 YR
-
-