MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-11-19 for DYNABLAST PASTE 1CC 10.210.1060 manufactured by Keystone Dental.
[4119939]
The clinician contacted keystone dental on (b)(6) 2013 and reported that a pt complained of a burning sensation immediately after placement of dyanblast paste. According to the incident narrative an implant was placed on (b)(6) 2012 at (b)(6). On (b)(6) 2013 the pt complained of soreness and irritation. Antibiotics treatment was prescribed on (b)(6) 2013. The site looked good during a post op visit on (b)(6) 2013, but coronal bone loss was observed on (b)(6) 2013, the area was red and inflamed. A second round of antibiotics treatment was prescribed on (b)(6) 2013, 9mm crestal bone loss was also evident. The site was grafted to mitigate crestal bone loss. On (b)(6) 2013 the area was still red and inflamed. The clinician removed the implant and graft.
Patient Sequence No: 1, Text Type: D, B5
[11459712]
This product is contract manufactured for keystone dental by (b)(4). Keystone dental has an exclusive license to sell the dynablast product for dental applications from (b)(4), the developer of the product. No additional complaints from this lot were identified during a review of keystone complaints database. (b)(4) performed a detailed review of the manufacturing records and verified that product was manufactured and released in accordance with the product specifications. (b)(4) review included the batch records, tissue bank donor record, demineralization record, and sterilization record. There were no anomalies found within these records. A review of the sterilization certificate of processing verified that the product was sterilized on (b)(4) 2012, in load 12h02 and was sterilized from dose 28. 4 kgy to 30. 9 kgy. The product was sterilized within specification of min dose 25. 0 kgy to max dose 35. 0 kgy. (b)(4) certifies the materials (products) received the indicated doses within the precision and accuracy of the dosimetry system employed. This product was sterilized to a sterility assurance level (sal) of 10-6. Keystone dental's investigation did not reveal any manufacturing or sterilization issues. However, it was determined that the site was inflamed at the time of grafting. The ifu warns against the use of dynablast in contraindicated pts. Keystone dental reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005990499-2013-00009 |
| MDR Report Key | 3529730 |
| Report Source | 05,07 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-10-21 |
| Date of Event | 2013-09-17 |
| Date Mfgr Received | 2013-10-21 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2014-01-09 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LIZ CACCIOLA, VP OPEARTIONS |
| Manufacturer Street | 144 MIDDLESEX TURNPIKE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7813283390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNABLAST PASTE 1CC |
| Product Code | NUN |
| Date Received | 2013-11-19 |
| Model Number | NA |
| Catalog Number | 10.210.1060 |
| Lot Number | 120922 |
| ID Number | NA |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYSTONE DENTAL |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-19 |