MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-01-10 for NUOSS CORTICAL 5091004 manufactured by Collagen Matrix, Inc..
[96846120]
Additional qc testing of the reserve samples confirmed that the product is conforming and met acceptance criteria. There are no indications that the product would not perform as designed.
Patient Sequence No: 1, Text Type: N, H10
[96846121]
The doctor stated that after noticing the bone quality was not what the doctor was used to seeing, the patient returned back to the office where the nuoss fell out of its graft site. Subsequent to the request for additional feedback, the clinician stated that following ridge preservation procedure an unspecified emergency event occurred during the healing process. At the time loose, unincorporated nuoss particles were found in the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2018-00001 |
| MDR Report Key | 7178425 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-09 |
| Date Mfgr Received | 2017-12-11 |
| Device Manufacturer Date | 2016-01-17 |
| Date Added to Maude | 2018-01-10 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GLORIA ZUCLICH |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal | 07436 |
| Manufacturer Phone | 2014051477 |
| Manufacturer G1 | COLLAGEN MATRIX, INC. |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUOSS CORTICAL |
| Generic Name | OSTEOGUIDE ANORGANIC BONE MINERAL |
| Product Code | NPM |
| Date Received | 2018-01-10 |
| Catalog Number | 5091004 |
| Lot Number | BMTU15N2 |
| Device Expiration Date | 2019-01-31 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLLAGEN MATRIX, INC. |
| Manufacturer Address | 15 THORNTON ROAD OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-10 |