MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for NUVASIVE PLATE MINI HELIX SPINE, 4MM X 15MM 7740240 manufactured by Nuvasive, Inc..
[184850795]
Mom anterior cervical diskectomy /fusion c5-6, c6-7 on (b)(6) /2020. Post op day 1 no left arm pain or numbness, no right arm pain or numbness. Pt stated he feels fine. Discharged home, f/u with dr (b)(6), neurosurgeon in 4 weeks. On (b)(6) 2020 seen in neurosurgeon office due to left arm pain and numbness and left posterior leg numbness. Cervical spine x-rays done on (b)(6) 2020 reviewed and show that bottom screws have pulled out. Graft intact. Ordered add'l studies and add'l surgery to remove plate and screws. Emg ordered left upper extremity no results available in hosp medical record. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093873 |
| MDR Report Key | 9865233 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-03-17 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE PLATE MINI HELIX SPINE, 4MM X 15MM |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| Product Code | KWQ |
| Date Received | 2020-03-20 |
| Model Number | 7740240 |
| Catalog Number | 7740240 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Brand Name | HEX SCREWS AND 4MM X 1500 |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| Product Code | KWQ |
| Date Received | 2020-03-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Brand Name | SPINE CERVICAL SCREW |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| Product Code | KWQ |
| Date Received | 2020-03-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-20 |