MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-02-25 for KYPHX HV-R BONE CEMENT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[184329892]
The following products have been used in the surgery: part# cx01a; lot# el70141; 510k# k102397; udi# (b)(4); qty# 1 part# cx01b; lot# 0010023931; 510k# k102397; udi# (b)(4); qty# 1. It is unknown which of these cement has extravasated. 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
[184329893]
Cement extravasation was not extruded > 15 mm it was reported via clinical study that patient underwent cementoplasty (kyphoplasty) surgery at inferior disk space. Intra-op, cement extravasation occurred. No patient complications were reported during this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00197 |
| MDR Report Key | 9748727 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-02-25 |
| 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 | KYPHX HV-R BONE CEMENT |
| Generic Name | CEMENT, BONE, VERTEBROPLASTY |
| Product Code | NDN |
| Date Received | 2020-02-25 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2020-02-25 |