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 2019-12-26 for T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM 436120C manufactured by Medtronic Sofamor Danek Usa, Inc.
[177987044]
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
[177987045]
Patient demographics: gender-female, pre-operative diagnosis: trauma, procedure: anterior fixation levels, implanted: l2 device, status: implanted-remains in service. Implant date: (b)(6) 2019. It was reported that the patient underwent anterior fixation due to trauma. Post-operatively, the self-adjusting end cap moved and the cage migrated. After posterior fixation was performed, the alleged cage was placed the next week. The self-adjusting end cap was inserted in a free state and the final tightening was performed following the surgical technique. At a later date, it was pointed out that the cage has migrated to the approaching side and the angle of the self-adjusting end cap has changed as well. The extended end cap of 45mm was used. There were no patient complication occur as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[187952864]
Radiographic image review result: post-op x rays for t12-l3 psi with l2 corpectomy performed by report. An ap view and single ct coronal slice are provided. The corpectomy cage is translated laterally which would be surprising if it was placed after the posterior instrumentation was already placed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2019-01482 |
| MDR Report Key | 9519163 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-26 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2019-12-26 |
| 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 | 2019-12-26 |
| Model Number | NA |
| Catalog Number | 436120C |
| Lot Number | UNK |
| 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 | 2019-12-26 |