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
- GRAFTON® DBM T43110INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 recall2 reports
- GRAFTON® DBM T43102INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 recall0 reports
- GRAFTON® DBM T43103INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 recall0 reports
- GRAFTON® DBM T43101INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 recall0 reports
- GRAFTON® DBM T43105INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 recall0 reports
- DynaBlast 10.210.1050Keystone Dental, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE3 reports
- GRAFTON® DBM T42308INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 report
- GRAFTON® DBM T43110INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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