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: DATUM DENTAL LTD. OSSIX BONE; BONE GRAFTING MATERIAL, FOR DENTAL BONE REPAIR
  • 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
 

DATUM DENTAL LTD. OSSIX BONE; BONE GRAFTING MATERIAL, FOR DENTAL BONE REPAIR Back to Search Results
Catalog Number 32310011
Device Problems Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 05/24/2021
Event Type  Injury  
Event Description
According to the available information, a (b)(6) years old female patient received a bonegraft with ossix bone 5*10*10 (0.5cc) in position 30 (fdi 46) on (b)(6) 2021.The bonegraft was removed on (b)(6) 2021 as it did not integrate.The bonegraft never integrated, it was lost (almost rejected) from the extraction site.The patient returned four days later with swelling and almost food impaction/dry socket symptoms.The ossix bonegraft partially "flaked" out and was acting more as a foreign body than integrating.It was suctioned out at time of debridement.There are a number of well-known complications using bonegraft techniques.This event is reportable per 21 cfr part 803 as dentsply sirona implants is the importer for this product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OSSIX BONE
Type of Device
BONE GRAFTING MATERIAL, FOR DENTAL BONE REPAIR
Manufacturer (Section D)
DATUM DENTAL LTD.
1, bat sheva st.
lod central, il 71201 01
IS  7120101
MDR Report Key12213409
MDR Text Key263095394
Report Number1222802-2021-00001
Device Sequence Number1
Product Code LPK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number32310011
Device Lot NumberOB50000142
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2021
Distributor Facility Aware Date06/21/2021
Event Location Other
Date Report to Manufacturer07/19/2021
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
-
-