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 2020-01-02 for T2 STRATOSPHEREEXPANDABLE CORPECTOMY SYSTEM 436120C manufactured by Medtronic Sofamor Danek Usa, Inc.
[183515857]
Other: thigh pain. 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
[183515858]
It was reported that the patient underwent posterior fixation, vertebral body replacement at l3 and anterior fixation was performed at l2-4 due to compression fracture at l3. It was unknown how much the cage backed out. The cage was placed in the state that the adjusting end caps were free according to the surgical technique, and the cage was lengthened. It was said the cage did not reach the vertebral body end plate during lengthening, and maybe the set screw on the side of the adjusting end caps side was not loosened enough, so the set screw was loosened after removal, and insertion was performed again, and at that time the cage was lengthened successfully. After placement, it was checked whether the cage moves using a spatula of the facility, and there was no problem. Post-operatively, the cage placed backed out towards the approached side. By checking the post-operative x-ray image, it seemed that the upper end plate side had not fit slightly. The patient had pain in the thigh.
Patient Sequence No: 1, Text Type: D, B5
[187446809]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2020-00001 |
| MDR Report Key | 9537454 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-01-02 |
| 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 STRATOSPHEREEXPANDABLE CORPECTOMY SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-01-02 |
| Model Number | NA |
| Catalog Number | 436120C |
| Lot Number | CA18J204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-02 |