MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-10-08 for DBP PUTTY 1CC 10-220-1030 manufactured by Iso Tis.
[3731966]
It was reported the clinician reopened a site grafted with dynablast putty placed at molar # 19, and found that there was no solid bone. The graft was removed and the site was re-grafted and the pt was sent home for a couple of months to reevaluate for bone to fill the site.
Patient Sequence No: 1, Text Type: D, B5
[11375108]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090010-2013-00014 |
| MDR Report Key | 3459089 |
| Report Source | 05,08 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-10-08 |
| Date Mfgr Received | 2013-09-18 |
| Date Added to Maude | 2014-01-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBP PUTTY 1CC |
| Generic Name | NA |
| Product Code | NUN |
| Date Received | 2013-10-08 |
| Catalog Number | 10-220-1030 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISO TIS |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-08 |