MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-04-22 for DYNABLAST PASTE 1CC 10-210-1060 manufactured by Seaspine Inc..
[142613419]
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.
Patient Sequence No: 1, Text Type: N, H10
[142613420]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2019-00002 |
| MDR Report Key | 8534704 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-21 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2019-03-22 |
| Date Added to Maude | 2019-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE CHAVEZ |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7602165109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNABLAST PASTE 1CC |
| Generic Name | BONE GRAFTING MATERIAL |
| Product Code | NUN |
| Date Received | 2019-04-22 |
| Model Number | 10-210-1060 |
| Lot Number | 102268 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEASPINE INC. |
| Manufacturer Address | 2 GOODYEAR IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-22 |