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 SIMPLY REPLANT 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 SIMPLY REPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 604313U
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Fibrosis (3167)
Date of Event 07/23/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient's dental implant failed to osseointegrate.The implant was removed four months after initial placement.Fibrous tissue was reported to be around the implant.
 
Additional Manufacturer Narrative
Followup is to add a comment to indicate that the initial report was late due to asr to individual reporting transition.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIMPLY REPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9045576
Report Number3001617766-2019-01122
Device Sequence Number11208722
Product Code DZE
UDI-Device Identifier10841307108313
UDI-Public10841307108313
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 09/16/2019
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 Expiration Date10/28/2023
Device Catalogue Number604313U
Device Lot Number126858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Initial Date Received by Manufacturer 08/06/2019
Supplement Date Received by Manufacturer08/06/2019
Initial Report FDA Received Date09/13/2019
Supplement Report FDA Received Date09/16/2019
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 Age73 YR
-
-