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 2020-01-15 for T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM 436120C manufactured by Medtronic Sofamor Danek Usa, Inc.
[175064086]
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
[175064087]
Levels implanted: l3-5 it was reported that the patient underwent replacement of l4 vertebral body due to pseudoarthrosis occurred after the vertebral body fracture at l4. Osteotomy on the contralateral side was not done enough during cage placement, so cage placement was performed near the approaching side. Although the surgeon also acknowledged that the osteotomy was not done enough, the operation was completed as it was. Post-op, on (b)(6) it was found by checking images during the two stage surgery of posterior fixation that 90% of the cage backed out. It was presumed that the cage backed out during the period from (b)(6) (after the operation) to (b)(6), and the anterior side of lumbar spine opened and the cage backed out when the patient was in supine position. It was planned to perform osteotomy on the contralateral side again and to place the cage from the anterior side on (b)(6). Device has been removed from the patient body in the revision surgery.
Patient Sequence No: 1, Text Type: D, B5
[188149166]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188149167]
Cage replacement was performed during the revision surgery, and revision surgery was completed without any problem. No health damage in the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00064 |
| MDR Report Key | 9590066 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-15 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| Model Number | NA |
| Catalog Number | 436120C |
| Lot Number | CA19C046 |
| 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. Required No Informationntervention | 2020-01-15 |