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 GO DIRECT COLLAR; DENTAL COLLAR
  • 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 GO DIRECT COLLAR; DENTAL COLLAR Back to Search Results
Catalog Number 423713-L
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Event Date 07/09/2020
Event Type  malfunction  
Manufacturer Narrative
Patient's weight is unknown.Udi number and k number do not apply to this product.
 
Event Description
Per complaint (b)(4), wrong implant were placed in the patient's mouth and there was no stability.Patient experienced no injuries.A second surgery is needed.
 
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.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GO DIRECT COLLAR
Type of Device
DENTAL COLLAR
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 e hillcrest dr.
thousand oaks, ca
MDR Report Key10468625
MDR Text Key204928354
Report Number3001617766-2020-06244
Device Sequence Number1
Product Code EIL
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
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number423713-L
Device Lot Number161834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age77 YR
-
-