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

Model Number	10-210-1060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Itching Sensation (1943)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: BONE GRAFTING MATERIAL
• Manufacturer (Section D): SEASPINE INC.; 2 goodyear; irvine CA 92618
• MDR Report Key: 8534704
• Report Number: 2090010-2019-00002
• Device Sequence Number: 10862718
• Product Code: NUN
• UDI-Device Identifier: D7681021010600
• UDI-Public: D7681021010600
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2019

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 Model Number: 10-210-1060
• Device Lot Number: 102268
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANTS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR