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 2020-02-23 for T2 SPINAL SYSTEM 9391316 manufactured by Medtronic Sofamor Danek Usa, Inc.
[187545049]
Adverse outcome: others: excessive bleeding. 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
[187545050]
It was reported that the patient presented with kyphosis and t10 vertebral body fracture; and underwent posterior fixation at t7-l3 after t10 vertebral column resection (vcr). Intra-op, after vcr was performed at t10 and cylinder of 13mm was placed at t2, x-ray (taken at the time of posterior fixation) revealed that the cage did not connect with the endplate of t9. The cranial side of the cage had deviated towards the anterior side of the t9 vertebral body and bleeding occurred. Since the image had not been confirmed when placing the cage, it was considered that there was a high possibility that the initial placing position was originally at the anterior side. Because of a large amount of bleeding, the surgeon decided to give up doing the operation such as re-placement of the cage, and wound closure was performed after finishing the posterior fixation. The end cap was not used. It was said that the cage seemed to be not contracted. The patient's condition was not confirmed. There was delay of more than 60 minutes in overall procedure. The assistant surgeon considered that it was not an injury to the blood vessels etc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00190 |
| MDR Report Key | 9742945 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-23 |
| Date of Report | 2020-02-23 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2017-04-05 |
| Date Added to Maude | 2020-02-23 |
| 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 | T2 SPINAL SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-02-23 |
| Model Number | NA |
| Catalog Number | 9391316 |
| Lot Number | UM16B001 |
| 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 | 1. Other | 2020-02-23 |