MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-22 for SUPERION INDIRECT DECOMPRESSION SYSTEM 102-9108 140-9800 manufactured by Vertiflex, Inc..
[126116930]
Upon receipt of the device, visual examination confirmed that the distal tip of the manual driver had fractured. The reporter noted that the patient was ankylosed and scoliotic, both of which conditions are contraindicated and would have caused significant resistance to proper alignment and deployment of the implant. Application of excessive force in deployment may have been proximate cause for the driver tip fracture, but the reporter also stated that due to difficulty in deployment of the implant, the treating physician "finished deployment with [a] mallet". This technique is not recommended, and may also have contributed to the driver tip fracture.
Patient Sequence No: 1, Text Type: N, H10
[126116931]
During attempts to place a superion ids implant at l4/l5, significant resistance to deployment was encountered. To overcome this resistance, excessive torque was applied by the treating physician in an attempt to deploy the implant, with the result that one (1) 10mm implant was broken. This implant was successfully removed without issue, and a second implantation attempted. While this implant was successfully placed, albeit after the physician used a mallet to finish deployment, during deployment the tip of the manual driver instrument fractured. A portion of the fractured tip remained firmly engaged within the distal end of the implant body, and was allowed by the physician to remain in situ. It is notable that the patient presented with both ankylosis and significant scoliosis, which are both contraindicated conditions, and would have been the proximate cause(s) of the resistance to deployment encountered. Several unsuccessful attempts have been made to contact the treating physician to discuss the ramifications of the driver fragment left in situ. We will continue to attempt to follow up with the clinician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005882106-2018-00007 |
| MDR Report Key | 7991718 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-22 |
| Date of Report | 2018-09-22 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2018-09-19 |
| Date Added to Maude | 2018-10-22 |
| 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 SPACER |
| Product Code | NQO |
| Date Received | 2018-10-22 |
| Returned To Mfg | 2018-09-19 |
| Model Number | 102-9108 |
| Catalog Number | 140-9800 |
| Lot Number | 183189 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-22 |