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 2020-02-10 for T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM 436120C manufactured by Medtronic Sofamor Danek Usa, Inc.
[187390468]
Outcomes to adverse event: other: fracture, delirium symptoms. 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
[187390469]
It was reported that the patient presented with l1 pseudoarthrosis; and underwent replacement of vertebral body by anterior approach. Placement of cage was performed at l1 in the first stage surgery; and oblique lumbar interbody fusion was performed at l2-l3. No complications or malfunctions were reported after this surgery. The second stage of surgery was to be performed on (b)(6) 2019. On the weekend after the first stage surgery, it was reported that the patient kicked the nurse with severe symptoms of delirium. In the morning of (b)(6) 2019, the surgeon was worried and x-rays taken before the operation revealed that the cage sank towards l2 endplate and the superior endplate of l2 fractured. There was a possibility that the l2 superior endplate got fractured because of the cage back-out. Bone quality of the patient was weak. It was unknown exactly what the cause was, but it seemed that the angle of the self-adjusting end cap had changed. Since it was not a major back-out, only the second stage surgery was performed (as it was planned). Posterior fixation was performed at t10-l4. Follow-up observations were planned for the patient. At the end of (b)(6), no further back-out of the cage has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00162 |
| MDR Report Key | 9689209 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-10 |
| 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 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-02-10 |
| Model Number | NA |
| Catalog Number | 436120C |
| Lot Number | CA18J204 |
| 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 | 2020-02-10 |