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 2020-01-16 for KYPHON HV-R BONE CEMENT C01A-J manufactured by Medtronic Sofamor Danek Usa, Inc.
[179255289]
Pma/510k: this part is not approved for use in the united states; however a like device catalog #: c01a, 510k #: k180700 and udi #: (b)(4) was cleared in the united states. Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179255290]
Pre-op diagnosis: primary osteoporosis it was reported that the patient underwent balloon kyphoplasty at l1 due to compression fracture. Intra-op, during cement filling, the cement flowed towards the vein on the left side of the vertebral body. No additional treatment was performed as a result of this event and the procedure was completed with the same product. There were no patient complications reported after the operation. The cement was mixed for 11 minutes and was in an appropriate condition being injected into the patient. Ct will be taken at a later date and the patient outcome would be confirmed then.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00078 |
| MDR Report Key | 9597629 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2020-01-16 |
| 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 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON HV-R BONE CEMENT |
| Generic Name | CEMENT, BONE, VERTEBROPLASTY |
| Product Code | NDN |
| Date Received | 2020-01-16 |
| Model Number | NA |
| Catalog Number | C01A-J |
| Lot Number | EL70110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |