MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-14 for SUPERION IDS 8MM SUPERION IDS 100-9808 manufactured by Vertiflex, Inc..
[117129518]
Physician reports that a patient he implanted with the superion device contacted him regarding onset of acute pain. Physician examined the patient and confirmed a spinous process fracture. Patient reports it occurred when line dancing. Physician advises he will treat for pain acutely and follow patient closely. Spinous process fractures are a recognized low-frequency risk associated with the subject device, and likelihood of occurrence is increased in the presence of certain known risk factors. It is not known whether any such risk factor(s) was (were) present in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005882106-2018-00003 |
| MDR Report Key | 7782904 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-07-20 |
| Date Added to Maude | 2018-08-14 |
| 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 | MR ROBERT REITZLER |
| Manufacturer Street | 2714 LOKER AVENUE WEST SUITE 100 |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal | 92010 |
| Manufacturer Phone | 4423255934 |
| Manufacturer G1 | VERTIFLEX, INC. |
| Manufacturer Street | 2714 LOKER AVENUE WEST SUITE 100 |
| 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 IDS |
| Generic Name | INTERSPINOUS SPACER |
| Product Code | NQO |
| Date Received | 2018-08-14 |
| Model Number | 8MM SUPERION IDS |
| Catalog Number | 100-9808 |
| Lot Number | 800013 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERTIFLEX, INC. |
| Manufacturer Address | 2714 LOKER AVENUE WEST SUITE 100 CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-14 |