MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-18 for KYPHX HV-R BONE CEMENT C01A-J manufactured by Mdt Kyphon Neuchatel Mfg.
| Report Number | 2953769-2020-00004 |
| MDR Report Key | 9719448 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-18 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MDT KYPHON NEUCHATEL MFG |
| Manufacturer Street | PIERRE- |
| Manufacturer City | NEUCH 2000 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX HV-R BONE CEMENT |
| Generic Name | CEMENT, BONE, VERTEBROPLASTY |
| Product Code | NDN |
| Date Received | 2020-02-18 |
| Model Number | NA |
| Catalog Number | C01A-J |
| Lot Number | EL70122 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT KYPHON NEUCHATEL MFG |
| Manufacturer Address | PIERRE-?-BOT 97 NEUCH?TEL 2000 CH 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |