MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-05 for PERX360 SYSTEM 6130-00 manufactured by Interventional Spine, Inc..
[17626250]
It was reported that when attempting to expand the cage using the inserter the expansion knob of the inserter became completely stuck and would not rotate in either direction. The surgeon completed the case using a different inserter.
Patient Sequence No: 1, Text Type: D, B5
[17899616]
The insertion tool was thoroughly examined upon receipt and found to have been "jammed" by over-tightening the expansion handle of the instruments. The cause has been determined to be that the surgical technician in the operating room did not reset the expansion gauge to "9mm" before attaching the cage to the instrument; therefore the insertion tool was left at or close to "14mm", which means that the cage could not be fully expanded during surgery. In this case, as the operating surgeon attempted to expand the implant, the insertion instrument became jammed, causing the instrument to be unable to be turned in either direction. Although the implant had to be removed from the patient during surgery, there was no patient harm, and only a minimal delay in surgery while cage implant was loaded onto another insertion instrument for implantation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2015-00001 |
| MDR Report Key | 4827078 |
| Report Source | 07 |
| Date Received | 2015-06-05 |
| Date of Report | 2015-06-03 |
| Date of Event | 2015-05-06 |
| Date Mfgr Received | 2015-05-06 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2015-07-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 13700 ALTON PKWY., SUITE 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERX360 SYSTEM |
| Generic Name | INSERTION TOOL |
| Product Code | MRW |
| Date Received | 2015-06-05 |
| Returned To Mfg | 2015-05-22 |
| Model Number | 6130-00 |
| Catalog Number | 6130-00 |
| Lot Number | 080112-A |
| ID Number | 8119540117894 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-05 |