MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-21 for SUPERION INTERSPINOUS SPACER manufactured by Vertiflex Inc..
[188807790]
A report was received that a patient developed a herpes simplex infection at the well healing implant site 10 days after the spacer was implanted. The patient developed clusters of small vesicles in the lumber region. The patient reported burning symptoms and a return of her inability to walk. The patient was initially treated with antibiotic but the infection did not resolve. The patient then developed a fever 14 days after implantation and was hospitalized. A spinous process fracture was also noted. The patient was then treated with a different iv antibiotic and the issue resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00724 |
| MDR Report Key | 9741679 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-25 |
| Date Mfgr Received | 2020-01-25 |
| Date Added to Maude | 2020-02-21 |
| 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 | 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 | 2020-02-21 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-21 |