MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for NOVABONE DENTAL PUTTY EU3620 manufactured by Novabone Products.
[110587767]
As a lot number was not provided, novabone has been able to narrow the possible source of the product. The product in question most likely came from one of these lots: lot # 1607b7, lot # 1607c1 , lot # 1612b6. Device history records for these lots were pulled and reviewed. No nonconformances or deviations were associated with these lots. Manufacturing, sterilization, and distribution were all conducted according to specification. A review of complaints from these lots and this product showed (b)(4) was received from lot 1607b7 with failure mode of empty cartridge. There were no complaints to date for lots 1607c1 and 1612b6. Since 2015, 32 complaints have been received for dental bioglass products with no reports of inflammation or infection. The 32 complaints were limited to broken cartridges and hard putty, no adverse events. Post market surveillance from 2016 and 2017 support the following conclusions: there is no evidence of quality problems associated with novabone devices. No corrective/preventative action is indicated. Residual risks are as expected. No new risks were identified. Novabone has identified the possibility of inflammation and revision surgery in risk analysis. While inflammation can be caused by non-sterile or contaminated devices, the records review and complaint history indicates these products were manufactured to specification. The likelihood that the novabone device contributed to this event is low when compared to the risks of the procedure itself.
Patient Sequence No: 1, Text Type: N, H10
[110587768]
The doctor indicated inflammation, infection, and removal on (b)(6) 2017. The part was not returned and the event was reported on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768919-2018-00001 |
| MDR Report Key | 7573084 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-08 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-06-06 |
| 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 | MR. RICHARD DAVIS |
| Manufacturer Street | 13510 NW US HIGHWAY 441 |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal | 32615 |
| Manufacturer Phone | 3865186992 |
| Manufacturer G1 | NOVABONE PRODUCTS |
| Manufacturer Street | 13510 NW US HIGHWAY 441 |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NOVABONE DENTAL PUTTY |
| Generic Name | NOVABONE DENTAL PUTTY |
| Product Code | LYC |
| Date Received | 2018-06-06 |
| Model Number | EU3620 |
| Catalog Number | EU3620 |
| Lot Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVABONE PRODUCTS |
| Manufacturer Address | 13510 US HIGHWAY 441 ALACHUA FL 32615 US 32615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-06-06 |