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 2020-03-16 for T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM 436120C manufactured by Medtronic Sofamor Danek Usa, Inc.
[188476295]
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
[188476296]
Pre op diagnosis: compression fracture procedure performed: anterior vertebral body replacement and posterior fixation were performed post op, after t3 insertion, compression fracture occurred at l3 due to which the implanted cage sank and backed out. The patient underwent revision surgery in which the fixation range of posterior fixation was changed from 1 above-1 below to 3 above-2 below. Autograft was placed where corpectomy was performed, and then the operation was finished.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00309 |
| MDR Report Key | 9834332 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-16 |
| 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 | 2020-03-16 |
| 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. Other; 2. Required No Informationntervention | 2020-03-16 |