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 2020-02-10 for SPINAL VERTEBRAL BODY REPLACEMENT DEVICE 2982240 manufactured by Medtronic Sofamor Danek Usa, Inc.
[178583357]
Neither the device nor films of applicable imaging studies were 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
[178583358]
It was reported that the patient presented with adult spinal deformity; and underwent oblique lumbar interbody fusion at l2-l3-l4. Intra-op, while using the product, it was confirmed from the image that it had accidentally advanced towards the spinal canal and injured the l2 right nerve root. As a result, bleeding occurred from the epidural vein layer. As the trial shape was dull at that time, the doctor considered that there was no problem and continued the operation. Eventually, nerve palsy was noticed after the operation. According to the nurse in the operation room, there was nerve root injury with the trial and stenosis due to hemostatic material placing. Owing to the technical error by the surgeon, a re-operation was performed on the same day. Nerve injury treatment and hemostasis were performed from posterior side and dura was sewn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00161 |
| MDR Report Key | 9688884 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-10 |
| 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 | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-02-10 |
| Model Number | NA |
| Catalog Number | 2982240 |
| Lot Number | UNK |
| 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. Life Threatening; 2. Required No Informationntervention | 2020-02-10 |