MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-14 for I-FACTOR PEPTIDE ENHANCED BONE GRAFT 700-050 manufactured by Cerapedics, Inc..
| Report Number | 3007155473-2019-00014 |
| MDR Report Key | 9321330 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-14 |
| Date of Report | 2019-11-12 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2018-09-28 |
| Date Added to Maude | 2019-11-14 |
| 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. MARK BOWERMAN |
| Manufacturer Street | 11025 DOVER ST. SUITE #1600 |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3039746275 |
| Manufacturer G1 | CERAPEDICS, INC. |
| Manufacturer Street | 11025 DOVER ST. SUITE #1600 |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-FACTOR PEPTIDE ENHANCED BONE GRAFT |
| Generic Name | BONE GRAFT |
| Product Code | NOX |
| Date Received | 2019-11-14 |
| Model Number | 700-050 |
| Catalog Number | 700-050 |
| Lot Number | 18C0493 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERAPEDICS, INC. |
| Manufacturer Address | 11025 DOVER ST. SUITE 1600 WESTMINSTER CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-14 |