MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-10-25 for DYNABLAST PUTTY 1CC 10.220.1030 manufactured by Keystone Dental.
[3851060]
The clinician contacted keystone dental on (b)(6) 2013 and stated he reopened a site grafted with dynablast and found that there was no solid bone. This procedure was completed in (b)(6) 2013, and implantation was attempted recently (about 5 months after bone grafting). The clinician uses dynablat product in many successful cases since 2009, and noted that the pt was a good candidate for this procedure and is relatively healthy. The site was re-grafted and the pt was sent home for a couple months to allow bone to fill the site. The graft was placed at molar number 19.
Patient Sequence No: 1, Text Type: D, B5
[11376814]
This product is contract manufacturer for keystone dental by integra lifesciences. Keystone dental has an exclusive license to sell the dynablast product for dental applications from integra lifesciences, the developer of the product. No additional complaints from this lot were identified during a review of keystone complaints database. Integra performed a detailed review of the manufacturing records and verified that product was manufactured and released in accordance with the product specifications. Integra's 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 12j25 and was sterilized from does 25. 0 kgy to 33. 9 kgy. The product was sterilized within specifications of min dose 25. 0 kgy to max dose 35. 0 kgy. Sterigenics certifies the materials (products) received the indicated doses within the precisions 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. The ifu states sites grafted with dynablast should be allowed to heal approximately 6 months prior to implant placement. Keystone dental considers this investigation closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005990499-2013-00005 |
| MDR Report Key | 3452869 |
| Report Source | 05,07 |
| Date Received | 2013-10-25 |
| Date of Report | 2013-09-27 |
| Date of Event | 2013-09-01 |
| Date Mfgr Received | 2013-09-27 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-12-09 |
| 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 |
| 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 PUTTY 1CC |
| Product Code | NUN |
| Date Received | 2013-10-25 |
| Model Number | NA |
| Catalog Number | 10.220.1030 |
| Lot Number | 121318 |
| ID Number | NA |
| Device Expiration Date | 2014-07-31 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-25 |