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 2020-03-11 for T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM 436120C manufactured by Medtronic Sofamor Danek Usa, Inc.
[188475189]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Radiographic image review result: three images provided for l2 corpectomy with anterior instrumentation and l1-l3 posterior stabilization. The first ap x-ray shows the interbody cage translated out of the corpecting defect. The second image shows the endcap not in contact with the l1 interior end plate. The third image shows contact with the end plate. It is probable that the cage chipped and lost contact with the endplates along it to translate laterally. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188475190]
It was reported that the patient underwent anterior vertebral body replacement at l2 due to burst fracture. Post-op, t3 backed out after it was inserted. Hence on (b)(6) 2020, during revision surgery, a patient position was taken and it was confirmed by checking the image that the implant has not been in contact with the endplate on the cranial side at all. It was performed after posterior fixation. The reason considered for backing out were the posterior screw loosened, and the anterior side opened. The t3 shrank after the operation. The third image was the image that was taken immediately after the operation. The frontal image right after the operation was not available, but it was considered that the position where the cage was placed had deviated a little from the center of the vertebral body. It was found that it has turned to the state of the first image three or four days after the initial surgery. The second image was taken during the revision surgery. When the implant was placed for the first time, it is unknown at this point that the implant has shrunk or the adjustable end cap was deviated. According to surgeon may be l3 had have compression fracture(it was unknown when compression fracture occurred). The product has been replaced with another implant on (b)(6). There were no other patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00299 |
| MDR Report Key | 9822049 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| 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. Required No Informationntervention | 2020-03-11 |