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 LEGACY¿2 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 LEGACY¿2 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 823716
Device Problem Device-Device Incompatibility (2919)
Patient Problem Failure of Implant (1924)
Event Date 03/15/2018
Event Type  malfunction  
Event Description
Per the complaint, the implant abutment fused to the implant.The doctor was unable to separate, unthreaded impression post from the implant once it was placed and required the removal of implant and placement of a new implant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEGACY¿2 IMPLANT
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
adrienne stott
3050 east hillcrest drive
thousand oaks, CA 91362
8184443300
MDR Report Key7653053
MDR Text Key113013405
Report Number3001617766-2018-00162
Device Sequence Number1
Product Code DZE
UDI-Device Identifier10841307101284
UDI-Public10841307101284
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090234
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Remedial Action Replace
Type of Report Initial
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Expiration Date12/26/2022
Device Catalogue Number823716
Device Lot Number105796
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age75 YR
-
-