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 2020-03-21 for SPINAL VERTEBRAL BODY REPLACEMENT DEVICE 2986055 manufactured by Medtronic Sofamor Danek Usa, Inc.
[186522660]
Outcomes attributed to adverse event: other: blood loss. 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
[186522661]
It was reported that the patient presented with degenerative kyphosis; and underwent oblique lumbar interbody fusion at l4-l5. Intra-op, after trial was inserted, bleeding amount increased. By checking sagittal image, it was found that the position of the trial was on the anterior side very much. Hemostasis was performed using floseal and avitene. The cage insertion was completed while performing hemostasis carefully. The bleeding amount was about 1800cc. The cause of the bleeding could not be identified, but it was considered that there was also a possibility that bleeding occurred during the removal of the intervertebral disc or during dealing with the vertebral endplate. According to the doctor, external iliac veins may have ruptured. There was a delay of less than 60 minutes in the overall procedure time. It was unknown how much the patient issue was resolved; but a posterior operation from t10-s2 was scheduled for (b)(6) 2020. On (b)(6) 2020, a two-stage surgery, posterior fixation at t9-s2 was performed. Posterior lumbar interbody fusion was performed at l5/s1 and osteotomy was performed at l3. Plif at l5-s1 was performed, followed by screw insertion, followed by osteotomy at l3, followed by rod placement. During rod placement, bleeding from the bone and a large amount of bleeding from the epidural venous plexus emerged. It occurred from the part where osteotomy was performed at l3, and it was difficult to perform hemostasis. Finally, the operation was completed as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00344 |
| MDR Report Key | 9863432 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-21 |
| Date of Report | 2020-03-21 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-21 |
| 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 | 2020-03-21 |
| Model Number | NA |
| Catalog Number | 2986055 |
| 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. Other; 2. Required No Informationntervention | 2020-03-21 |