MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-05 for SYMBIOS XENOGRAFT GRANULES 32310001 manufactured by Collagen Matrix, Inc..
[64019796]
Report of exuberant growth of bulbous, fibrous mass over the extraction site was received, the mass was excised and submitted for histopathological evaluation by the clinician. Collagen matrix, inc. Has not received the evaluation results from the reporting clinician. The product was left in place and the patient was doing well at the time of reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2017-00001 |
| MDR Report Key | 6227247 |
| Date Received | 2017-01-05 |
| Date of Report | 2017-07-05 |
| Date Mfgr Received | 2016-11-30 |
| Device Manufacturer Date | 2016-07-06 |
| Date Added to Maude | 2017-01-05 |
| 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 | 0 |
| Brand Name | SYMBIOS XENOGRAFT GRANULES |
| Generic Name | PORCINE ANORGANIC BONE MINERAL |
| Product Code | NPM |
| Date Received | 2017-01-05 |
| Catalog Number | 32310001 |
| Lot Number | PMCU15H3 |
| Device Expiration Date | 2018-07-31 |
| 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 | 4 | 1. Other | 2017-01-05 |