MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-30 for NUOSS CANCELLOUS 509 9002 manufactured by Collagen Matrix, Inc..
[118879860]
Additional testing performed on the reserve product samples confirms that the product meets acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10
[118879861]
The clinician reported that the patient underwent a bone graft procedure and observed no integration. The material appeared discolored and darker in shade. No infection was observed. The clinician performed a follow-up procedure to remove the original bone graft and re-grafted the site using another product. There was a delay in placement of implant 4 to 6 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2018-00009 |
| MDR Report Key | 7834348 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-28 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2016-01-05 |
| Date Added to Maude | 2018-08-30 |
| 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 CANCELLOUS |
| Generic Name | BONE GRAFTING MATERIAL |
| Product Code | NPM |
| Date Received | 2018-08-30 |
| Model Number | 509 9002 |
| Lot Number | BM2CU15P1 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-08-30 |