MAUDE Adverse Event Report: INTERVENTIONAL SPINE, INC. PERX360 SYSTEM; INSERTION TOOL

Model Number 6130-00

Device Problems Misassembled (1398); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: PERX360 SYSTEM
• Type of Device: INSERTION TOOL
• Manufacturer (Section D): INTERVENTIONAL SPINE, INC.; irvine CA
• Manufacturer Contact: 13700 alton pkwy., suite 160; irvine, CA 92618 ; 9494720006
• MDR Report Key: 4827078
• MDR Text Key: 17626250
• Report Number: 2032499-2015-00001
• Device Sequence Number: 1
• Product Code: MRW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6130-00
• Device Catalogue Number: 6130-00
• Device Lot Number: 080112-A
• Other Device ID Number: 8119540117894
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention