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 IMPLANT ANALOG; 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 IMPLANT ANALOG; DENTAL IMPLANT Back to Search Results
Catalog Number 8035-06D
Medical Device Problem Code Missing Information (4053)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Indicated ni for no information available for lot #.Device manufacture date and expiration dates are unknown.This complaint was identified internally and generated for ncmr 10276.Per the ncmr, the part will be destroyed.
 
Event or Problem Description
Per complaint (b)(4), during an internal review, a part was identified as missing a label.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEGACY IMPLANT ANALOG
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key9873304
Report Number3001617766-2020-02946
Device Sequence Number16283908
Product Code NDP
UDI-Device Identifier10841307122821
UDI-Public10841307122821
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number8035-06D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/01/2019
Initial Report FDA Received Date03/24/2020
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;
-
-