MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-14 for SUPERION INDIRECT DECOMPRESSION SYSTEM 101-0110 101-9810 manufactured by Vertiflex, Inc..
[127212968]
Intraoperative fluoroscopic imaging obtained during the (b)(6) 2018 treatment procedure and provided to the manufacturer confirmed that the superior and inferior "wings" of both the l3/l4 and l4/l5 implants encompassed the lateral aspects of the l3, l4, and l5 spinous processes, although evidence of scoliosis was also apparent, such that the l4/l5 implant was rotated somewhat, and the l4 spinous process was not fully seated within the superior cam lobe of the implant. Imaging obtained at the time of the (b)(6) 2018 revision procedure confirmed that the superior "wing" of the l4/l5 implant was displaced laterally, such that it no longer captured the l4 spinous process (although the l5 spinous process remained correctly seated within the implant). Subsequent imaging acquired after the physician re-positioned the displaced implant during the (b)(6) 2018 revision depicts appropriate implant placement. It should be noted that scoliosis, defined as a cobb angle of >10 degrees, is contraindicated for the superion device. We do not have access to the imaging that would permit measurement of the cobb angle, but the scoliosis apparent in the imaging provided by the physician suggests that this condition may have contributed to the displacement.
Patient Sequence No: 1, Text Type: N, H10
[127212989]
Approximately a week after implantation of two (2) superion devices at l3/l4 and l4/l5 on (b)(6) 2018, the patient reported "pain/aching" in his back at the site of implantation. The physician acquired a/p and lateral x-rays, and confirmed from this imaging that the superior "wing" of the l4/l5 implant, which intraoperative imaging had confirmed was appropriately located, was now displaced laterally, such that the two sides of the "wing" were no longer capturing the l4 spinous process. On (b)(6) 2018 the physician performed a second procedure and repositioned the same implant properly, with the "wing" more securely capturing the l4 spinous process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005882106-2018-00009 |
| MDR Report Key | 8072045 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-11-14 |
| 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 INDIRECT DECOMPRESSION SYSTEM |
| Generic Name | INTERSPINOUS PROCESS SPACER |
| Product Code | NQO |
| Date Received | 2018-11-14 |
| Model Number | 101-0110 |
| Catalog Number | 101-9810 |
| Lot Number | 800044 |
| 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. Required No Informationntervention | 2018-11-14 |