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 2020-03-25 for T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM 436120450 manufactured by Medtronic Sofamor Danek Usa, Inc.
[185036730]
Fracture. Product was not 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
[185036731]
It was reported that the patient underwent vertebral body anterior replacement at l2 due to compression fracture of vertebral body. Post-op, it was found that the cage has backed out by checking x-ray image after 2 weeks of operation. The patient was able to walk with a cane and there was no health damage in the patient at this point. However, it was checked by image that the extended endcap has contacted with the kidney and it was forecasted that serious damage will occur if the cage contacts with the anterior major blood vessel. Bone quality was very bad. It was found by checking the x-ray image taken in the first week after the operation that the vertebral body of the most upper level fractured. Maybe the screw at l4 loosened. Hence an revision surgery performed on (b)(6) 2020 in which all of the screws on the posterior side were removed and to replace the screws with thick screws and after that, retrieve the cage which backed out to the anterior side and to insert autologous bone.
Patient Sequence No: 1, Text Type: D, B5
[187950013]
Radiographic image review result: ct images for vertebral corpectomy and posterior spinal instrumentation provided. Levels are unknown, appear to be thoracic lumbar. The anterior vertebral body graft has translated laterally out of the corpectomy defect and does not appear to be expanded to the correct height. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2020-00372 |
| MDR Report Key | 9881765 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-25 |
| 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 | T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-03-25 |
| Model Number | NA |
| Catalog Number | 436120450 |
| Lot Number | CA18G034 |
| 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; 2. Required No Informationntervention | 2020-03-25 |