MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-02-21 for OMEGA-21 VERTEBRAL FIXATION SYSTEM N/A UNK manufactured by Biomet Spain, S.l..
| Report Number | 0009610576-2020-00001 |
| MDR Report Key | 9738396 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-21 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET SPAIN, S.L. |
| Manufacturer Street | CALLE ISLAS BALEARES, #50 P.O. BOX 96 |
| Manufacturer City | FUENTE DEL JARRO, VALENCIA 46988 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 46988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMEGA-21 VERTEBRAL FIXATION SYSTEM |
| Generic Name | SPINE PROSTHESIS |
| Product Code | MNH |
| Date Received | 2020-02-21 |
| Model Number | N/A |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPAIN, S.L. |
| Manufacturer Address | CALLE ISLAS BALEARES, #50 P.O. BOX 96 FUENTE DEL JARRO, VALENCIA 46988 SP 46988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |