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 REPLUS 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 REPLUS IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 704210
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Discomfort (2330)
Date of Event 03/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption # e2012017.Report late due to asr to individual reporting transition.
 
Event or Problem Description
Per complaint (b)(4), during post operative check, patient experienced loss or failure of implant to integrate and patient also experienced inflamation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REPLUS IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8979551
Report Number3001617766-2019-01431
Device Sequence Number19664252
Product Code DZE
UDI-Device Identifier10841307104247
UDI-Public10841307104247
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K073161
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
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) 09/10/2019
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 Date10/21/2018
Device Catalogue Number704210
Device Lot Number45972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/13/2019
Initial Report FDA Received Date09/10/2019
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 Age63 YR
-
-