MAUDE Adverse Event Report: AURORA SPINE, INC. ZIP INTERSPINOUS FUSION SYSTEM; SPINOUS PROCESS PLATE, SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 108-02610-0810

Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

During transforaminal lumbar interbody fusion at l4-l5, the surgeon attempted to place an aurora titanium coated peek spacer, however the insertion handle was unable to be removed from the peek spacer.Decision was made at that point to transition to a different interbody spacer.Introducer on engagement to the implant, locked and would not release.After manipulation to remove, it broke in the hands of the surgeon.All pieces removed from surgical field, no harm to patient, no retained pieces as verified by x-ray.

• Brand Name: ZIP INTERSPINOUS FUSION SYSTEM
• Type of Device: SPINOUS PROCESS PLATE, SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): AURORA SPINE, INC.; 1920 palomar point way; carlsbad CA 92008
• MDR Report Key: 4486492
• MDR Text Key: 5497909
• Report Number: 4486492
• Device Sequence Number: 1
• Product Code: PEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/29/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 108-02610-0810
• Device Lot Number: 1164-31
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2015
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 74