MAUDE Adverse Event Report: SEASPINE INC. DYNABLAST PASTE 1CC BONE GRAFTING MATERIAL

Model Number 10-210-1060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Itching Sensation (1943)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was conducted for lot 102268, and it was concluded that the products were inspected and accepted for use by the quality control department on 09/27/10 and met all specified parameters of the receiving inspection report (rir) with no associated nonconformances. Donor records were also reviewed, and product was approved on 09/23/09. The device was unable to be evaluated as the paste remained implanted. However, a medical review and assessment of the event was completed and determined that the reaction was a result of the restorative metals used in the procedure and that the fibrous strands were likely not related to the dynablast paste, as the material could not be identified in the pathology reports and dynablast paste is not comprised of fibrous strands. The reported allegation of post-operative reaction due to dynablast paste was not confirmed. A root cause of the fibrous strands was undetermined, and the reaction was determined to be the result of the restorative metals. Additionally, it was found during the investigation that the implants were placed 3 months after grafting with dynablast. Per the dfu, implant placement should begin approximately 6 months after grafting with dynablast. Review of labeling notes: warnings and precautions: sites grafted with dynablast should be allowed to heal approximately 6 months prior to implant placement.

Event Description

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.

Manufacturer Narrative

This supplemental is to retract report 2090010-2019-00002, submitted in error, as keystone dental is responsible for mdr reporting requirements per quality agreement.

• Brand Name: DYNABLAST PASTE 1CC
• Type of Device: BONE GRAFTING MATERIAL
• Manufacturer (Section D): SEASPINE INC.; 2 goodyear; irvine CA 92618
• Manufacturer Contact: stephanie chavez ; 5770 armada drive; carlsbad, CA 92008 ; 7602165109
• MDR Report Key: 8534704
• MDR Text Key: 142613419
• Report Number: 2090010-2019-00002
• Device Sequence Number: 1
• Product Code: NUN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 10-210-1060
• Device Lot Number: 102268
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/22/2019 Patient Sequence Number: 1

Treatment

DENTAL IMPLANTS