MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-10-08 for DYNABLAST PUTTY 1CC 10.220.1030 manufactured by Keystone Dental.
[3775751]
The clinician contacted (b)(4) 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 dynablast product in many successfully 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 #19.
Patient Sequence No: 1, Text Type: D, B5
[11140654]
This product is contract manufactured for (b)(4) by integra lifesciences. (b)(4) has an exclusive license to sell the dynablast product for dental applications from integra lifescience, the developer of the product. No lot number was provided despite several f/u attempts, not having a lot number precluded a thorough review of keystone dental complaint database and integra's ability to performed a detailed review of batch records, tissue bank donor record, demineralization record, and sterilization record. The root cause of this occurrence could not be determined. Keystone dental does not anticipated any add'l info and therefore, considers this investigation closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005990499-2013-00003 |
| MDR Report Key | 3410454 |
| Report Source | 05,07 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-09-10 |
| Date of Event | 2013-09-01 |
| Date Mfgr Received | 2013-09-10 |
| Date Added to Maude | 2013-11-14 |
| 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 | 2013-10-08 |
| Model Number | NA |
| Catalog Number | 10.220.1030 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2013-10-08 |