MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-01 for SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) DRIVER 102-9108 manufactured by Vertiflex, Inc..
[126663746]
The report from the manufacturer's representative who was observing the clinical case indicated that the interspinous space into which the implant was being placed was "very tight," and resisted placement and deployment of the implant. The physician considered aborting the procedure for this reason, but eventually elected to try to proceed. In attempting to place and deploy (open) the implant despite significant resistance from the "very tight" anatomy, the representative believes that the physician exerted excessive torque to the manual driver instrument, at which time the distal tip of the driver fractured. Multiple attempts were made to retrieve the driver fragment (including suction and grasping the fragment with forceps), but the fragment was firmly embedded in the distal end of the implant. Since the implant was fully deployed and acceptably placed, and the driver fragment was so firmly attached to the implant, the physician elected to leave it in situ and close. The physician has been advised of the potential risks associated with allowing this fragment to remain in situ.
Patient Sequence No: 1, Text Type: N, H10
[126663747]
During attempts to place a superion ids at l3/l4, the distal tip of the manual driver instrument broke off. The fragment was firmly lodged in the proximal end of the implant, and resisted the physician's efforts to extract it. As it was firmly attached to the implant, and the implant was correctly placed, the physician elected to leave it in place and close. The company representative who was observing the case reports that the interspinous space into which the implant was being placed was "very tight" such that significant resistance to implant deployment was experienced. He suggested that the physician applied excessive torque to the driver to complete implant placement, which may have exceeded the strength of the driver, resulting in the fracture of the distal tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005882106-2018-00008 |
| MDR Report Key | 8029272 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-10-24 |
| Date Added to Maude | 2018-11-01 |
| 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 (IDS) |
| Generic Name | INTERSPINOUS SPACER |
| Product Code | NQO |
| Date Received | 2018-11-01 |
| Returned To Mfg | 2018-10-29 |
| Model Number | DRIVER |
| Catalog Number | 102-9108 |
| Lot Number | 183240 |
| 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 | 2018-11-01 |