MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-17 for KYPHON EXPRESS F06B manufactured by Medtronic Sofamor Danek Usa, Inc.
[97473587]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[97473588]
It was reported that patient was presented with 6 level painful vertebral compression fractures with levels implanted at t7-11. Intr a-op, the tip of the directional bone filler broke off when surgeon tried to remove it. It appeared to have snapped due to the torque from trying to twist it free. Product came in contact with the patient. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[104805878]
Additional information: device evaluation: the bone filler and tamp were returned with cement hardened inside. The back of the directional filler has been pulled out, from what appears to be excessive force. Per the reported event, the cement hardened faster than expected, causing the directional filler to become stuck. Since the cement was hardened when returned the setup time is unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2018-00074 |
| MDR Report Key | 7198739 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-17 |
| Date of Report | 2018-04-10 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2018-03-14 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2018-01-17 |
| 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 EXPRESS |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-01-17 |
| Returned To Mfg | 2018-03-07 |
| Model Number | NA |
| Catalog Number | F06B |
| Lot Number | WI463434 |
| Device Expiration Date | 2018-10-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2018-01-17 |