MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-25 for PERIOGLAS NA0260 manufactured by Novabone Products, Llc.
[137020477]
The device history records for lot 1709b2 were reviewed. No nonconformances or deviations were associated with the lot. Manufacturing, sterilization, and distribution were all conducted according to specification. This device is terminally sterilized using gamma irradiation. No product was returned for review. A review of complaints from indicated no other issues with lot 1709b2. No complaints of infection, inflammation, or allergic reactions have been received for perioglas (dental particulate bone graft) devices. The likelihood that the novabone device contributed to this event is low when compared to the procedure risks itself.
Patient Sequence No: 1, Text Type: N, H10
[137020478]
Report received that the last 4 patients who had product code: na0260 implanted of lot: 1709b2 required graft removal due to "allergic reaction", swelling, pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768919-2019-00001 |
| MDR Report Key | 8366654 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-19 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2018-04-15 |
| Date Added to Maude | 2019-02-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER KIBLER |
| Manufacturer Street | 13510 NW US HIGHWAY 441 |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal | 32615 |
| Manufacturer Phone | 3865186992 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOGLAS |
| Generic Name | SYNTHETIC BONE GRAFT |
| Product Code | LYC |
| Date Received | 2019-02-25 |
| Model Number | NA0260 |
| Catalog Number | NA0260 |
| Lot Number | 1709B2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVABONE PRODUCTS, LLC |
| Manufacturer Address | 13510 NW US 441 ALACHUA FL 32615 US 32615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-25 |