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 2019-04-22 for PYRAMESH C TITANIUM MESH G9050713 manufactured by Warsaw Orthopedics.
[142608852]
Common device name: spinal mesh system (spinal vertebral body replacement device). This part is not approved for use in the united states; however a like device catalog # 9050713, 510k #k011406, (b)(4) was cleared in the united states. 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. Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142608853]
Pre-operative diagnosis: cervical spondylotic radiculopathy(csr) procedure: anterior cervical decompression and fusion (acdf), c5 subtotal removal, surgical approach placement of product: inside intervertebral disc space posterolateral it was reported that bleeding from deep area of epidural venous plexus occurred during inserting device. Because while inserting the device, it was necessary to hammer it in, so maybe the vein plexus got injured at that time. Or maybe the vein plexus got injured when performing decompression. Treatment has been given to stop bleeding, the patient returned from the operation room and then there was nausea, and a drug to stop nausea was given to the patient. After that, the patient's breathing became unstable, the patient could not respond when someone was talking to the patient, and the patient became unable to say a word. After intubation and administration of steroid etc. , the patient's awareness became clear. The patient could walk now and was recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00457 |
| MDR Report Key | 8535280 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2013-08-23 |
| Date Added to Maude | 2019-04-22 |
| 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 | WARSAW ORTHOPEDICS |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PYRAMESH C TITANIUM MESH |
| Generic Name | MESH, METAL |
| Product Code | EZX |
| Date Received | 2019-04-22 |
| Model Number | NA |
| Catalog Number | G9050713 |
| Lot Number | 0278417W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-22 |