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 SIMPLYLEGACY DRIVER; 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 SIMPLYLEGACY DRIVER; DENTAL IMPLANT Back to Search Results
Catalog Number HT2.5LG
Device Problem Positioning Failure (1158)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
Event date were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient weight is unknown.Explanted date is not applicable since the product was not removed.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.Pma/510(k) - not applicable.
 
Event Description
Per (b)(4), during clinical procedure, components could not be separated.
 
Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIMPLYLEGACY DRIVER
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key12232540
MDR Text Key263845057
Report Number3001617766-2021-04455
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307119852
UDI-Public10841307119852
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHT2.5LG
Device Lot Number147440
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Date Manufacturer Received08/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-