MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-27 for SUPERION INTERSPINOUS SPACER manufactured by Vertiflex Inc..
[181921393]
A report was received that three days following the implant the patient reported worsening pain in a pre-existing pain area. Mri revealed a small left l3 l4 lateral disc extrusion with mild foraminal narrowing. Patient tried conservative measures for 1 month, however, those were not successful. The patient then underwent a left l3 l4 microdiscectomy which relieved radiculopathy, but not axial back pain. With physical therapy and increased medication for two months pain still persisted. New mri ordered showed a small l3 inferior endplate abnormality which was not present in previous mris. Abnormalities found on postop mri may be an endplate fracture at the level of the iss device. Postoperative ct was inconclusive for endplate fracture. Possible causes of this patient's disc herniation post implantation may include non-compliance to tlso brace and obesity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00843 |
| MDR Report Key | 9766453 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-27 |
| 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 | TALAR TAHMASIAN |
| Manufacturer Street | 25155 RYE CANYON LOOP |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6619494863 |
| Manufacturer G1 | VERTIFLEX INC. |
| Manufacturer Street | 2714 LOKER AVE. WEST |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERION INTERSPINOUS SPACER |
| Generic Name | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
| Product Code | NQO |
| Date Received | 2020-02-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERTIFLEX INC. |
| Manufacturer Address | 2714 LOKER AVE. WEST SUITE 100 CARLSBAD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |