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 823706
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 05/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's identifier and weight were not provided.When the requested information becomes available, a supplementary report will be submitted.Lot information is unknown.If additional information becomes available a supplementary report will be submitted.Pma/510(k) - not applicable.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), during clinical procedure, patient experienced failure of implant to integrate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEGACY 2 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key10874516
Report Number3001617766-2020-08154
Device Sequence Number2828612
Product Code DZE
UDI-Device Identifier10841307101239
UDI-Public10841307101239
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Catalogue Number823706
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/24/2020
Initial Report FDA Received Date11/20/2020
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 Age51 YR
-
-