MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-15 for NUBIC NB071317 manufactured by Signus Medizintechnik Gmbh.
| Report Number | 9615021-2019-00005 |
| MDR Report Key | 9189985 |
| Date Received | 2019-10-15 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-10-04 |
| Date Mfgr Received | 2019-10-04 |
| Date Added to Maude | 2019-10-15 |
| 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. FRANK OCZKOWSKI |
| Manufacturer Street | INDUSTRIESTRASSE 2 |
| Manufacturer City | ALZENAU, BAVARIA 63755 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63755 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUBIC |
| Generic Name | NUBIC PEEK CERVICAL CAGE 7X13X17MM |
| Product Code | ODP |
| Date Received | 2019-10-15 |
| Returned To Mfg | 2019-10-08 |
| Model Number | NUBIC |
| Catalog Number | NB071317 |
| Lot Number | 816889-AV |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIGNUS MEDIZINTECHNIK GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 2 ALZENAU, 63755 GM 63755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-15 |