• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KEYSTONE DENTAL INC DYNABLAST PASTE 0.5CC

  • 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
 

KEYSTONE DENTAL INC DYNABLAST PASTE 0.5CC Back to Search Results
Catalog Number 10.210.1050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 12/05/2016
Event Type  Injury  
Manufacturer Narrative
Graft remains implanted.
 
Event Description
This clinician contacted keystone dental on (b)(6) 2016 to report that a patient receiving dyanblast paste following an immediate extraction and grafting procedure 2 weeks ago had complained of pain, numbness, and swelling at the grafting site. According to the incident narrative, the tooth at fdi-iso dental site 33, was extracted on (b)(6) 2016 and immediately grafted with dynablast paste. On (b)(6) 2016, the patient reported regaining feeling at the grafting site.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDYNABLAST PASTE 0.5CC
Type of DeviceDYNABLAST PASTE 0.5CC
Manufacturer (Section D)
KEYSTONE DENTAL INC
154 middlesex tpk
burlington MA 01803 4403
Manufacturer (Section G)
KEYSTONE DENTAL INC
154 middlesex tpk
burlington MA 01803 4403
Manufacturer Contact
josh harkess
154 middlesex turnpike
burlington, MA 01803
7813283526
MDR Report Key6254154
MDR Text Key64903904
Report Number3005990499-2016-00007
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Dental Assistant
Type of Report Initial
Report Date 01/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Expiration Date02/28/2018
Device Catalogue Number10.210.1050
Device Lot Number155744
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/16/2017 Patient Sequence Number: 1
-
-