MAUDE Adverse Event Report: DYNAB; DYNABLAST PASTE SYRINGE 0.5CC

Model Number	10.210.1050
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The doctor removed the graft per the patient request.We have confirmed with seaspine that dynablast does not contain recombinant bmp-2, as found in medtronic's infuse products.Dynablast contains demineralized bone matrix (dbm) and an inert polymer carrier for handling.Dbm contains physiologic levels of growth factors that participate in bone remodeling.Like the patient's own bone, in the form of autograft, allografts such as dbms, contain naturally occurring bmp-2 along with other necessary inductive proteins that act in concert to promote healing.In addition, dhr review for 10-210-1050 dynablast paste 0.5cc lot # 176806 indicates the lot was completed and accepted for use on 10/6/2020.Its expiration date is 10/28/2022.Per the batch record, the lot met all requirements for acceptance, and of qty (120), all units were accepted.This lot has not been associated with any prior complaint.Additionally, there are no nonconformances or deviations which impact this lot.There are no records of similar reports with respect to potential immunogenic response to the dynablast product.Lastly, it was confirmed with the customer that at the patient latest appointment he checked the explant site in question and that the site has completely healed and looks within normal limits.
Event or Problem Description
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.

• Brand Name: DYNAB
• Common Device Name: DYNABLAST PASTE SYRINGE 0.5CC
• MDR Report Key: 11770814
• Report Number: 3005990499-2021-28179
• Device Sequence Number: 11870621
• Product Code: NUN
• UDI-Device Identifier: D7681021010500
• UDI-Public: +D7681021010500/$$7176806N
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: 10.210.1050
• Device Catalogue Number: 10.210.1050
• Device Lot Number: 176806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR