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DynaBlast 10.210.1050Recalls & reported problems

Keystone Dental, Inc. · Biomaterials · Class 2

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D7681021010500), received between Jan 16, 2017 and May 4, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 Problem2
  • Insufficient Device Problem Information1

Patient problems

  • Pain2
  • Impaired Healing1
  • Numbness1
  • Swelling1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT INITIALLY INQUIRED WITH THE DOCTOR ABOUT THE CONTENTS CONTAINED IN THE DYNABLAST PRODUCT DUE TO CONCERNS WITH BMP-2 COMPLICATIONS IN THE PAST. IN ADDITION, THE PATIENT ALLEGED THAT SHE HAD A BONE TYPE GROWTH AT THE EXTRACTION SITE AND THAT SHE BELIEVED THE PRODUCT HAS CAUSED HER HARM.

    Patient problems: Impaired Healing

    MAUDE report 11770814 ↗
  • InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem

    THIS CLINICIAN CONTACTED KEYSTONE DENTAL ON 12/15/2016 TO REPORT THAT A PATIENT RECEIVING DYANBLAST PASTE FOLLOWING AN IMMEDIATE EXTRACTION AND GRAFTING PROCEDURE 2 WEEKS PRIOR HAD COMPLAINED OF PAIN, NUMBNESS, AND SWELLING AT THE GRAFTING SITE. ACCORDING TO THE INCIDENT NARRATIVE, THE TOOTH AT FDI-ISO DENTAL SITE 36, WAS EXTRACTED ON (B)(6) 2016 IMMEDIATE PLACEMENT OF AN IMPLANT AND GRAFTED AROUND THE IMPLANT WITH DYNABLAST PASTE. ON 12/12/2016, THE PATIENT REPORTED THAT THE NUMBNESS AND PAIN WERE IMPROVING BUT NOT COMPLETELY RESOLVED. THE CLINICIAN REPORTED THE T THE IMPLANT WAS HEALING WELL WITH OUT ISSUE.

    Patient problems: Numbness; Pain; Swelling

    MAUDE report 6254528 ↗
  • InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Pain

    MAUDE report 6254154 ↗

Other BONE GRAFTING MATERIAL, HUMAN SOURCE devices

All BONE GRAFTING MATERIAL, HUMAN SOURCE devices →

Sources and updates

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