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DynaBlast 10.210.1060Recalls & reported problems

Keystone Dental, Inc. · Biomaterials · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D7681021010600), received between Apr 22, 2019 and Apr 22, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Inflammation1
  • Itching Sensation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IN (B)(6) 2011, THE PATIENT RECEIVED DYNABLAST PASTE IN LOCATION #30. IN (B)(6) 2011 SHE RECEIVED AN IMPLANT AT THE SITE AND RESTORATION WAS COMPLETED IN (B)(6) 2011. IN 2014, THE PATIENT BEGAN PULLING FIBROUS STRANDS OUT OF THE SITE. A PATHOLOGY REPORT WAS PERFORMED ON (B)(6) 2014, AND THE RESULTS WERE INCONCLUSIVE. IN 2015, THE PATIENT BEGAN TO EXPERIENCE INFLAMMATION AND ITCHING AROUND THE SITE AND SHE CONTINUED TO PULL OUT FIBROUS STRANDS. AN ADDITIONAL PATHOLOGY REPORT WAS PERFORMED ON (B)(6) 2015 WHICH CONCLUDED THAT SHE HAD TYPE IV HYPERSENSITIVITY TO THE METALS USED IN THE RESTORATION AND ALL RESTORATIVE COMPONENTS WERE REMOVED. HOWEVER, THE PATIENT CONTINUED TO EXPRESS SIGNS OF ALLERGIC REACTION AND FIBROUS STRANDS. PATIENT WAS CONCERNED THAT THE ISSUE MAY HAVE BEEN WITH THE BONE GRAFT MATERIAL. AT THE TIME OF CONTACT, NO ADDITIONAL EVENT INFORMATION WAS AVAILABLE.

    Patient problems: Inflammation; Itching Sensation

    MAUDE report 8534704 ↗

Other BONE GRAFTING MATERIAL, HUMAN SOURCE devices

All BONE GRAFTING MATERIAL, HUMAN SOURCE devices →

Sources and updates

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