MAUDE Adverse Event Report: AURORA SPINE, INC ZIP INTERSPINOUS FUSION SYSTEM; INTERSPINOUS FUSION DEVICE

Model Number 001-010-S-ZIP

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/08/2014

Event Type  Injury  

Event Description

The surgeon performed an emergency zip implant on the night of (b)(6) 2014 due to an acute infection.The device was originally implanted on (b)(6) 2014.The implant and graft were sent to pathology for examination.The pt is recovering.At this time, the surgeon does not believe the implant and graft were the causative reason for infection.The surgeon sent a follow-up email on 12/16/2014 stating, "no idea why he got infection but do not see zip as a reasonable cause.Perhaps pt disease.Infections are a risk factor with any surgery.".

Manufacturer Narrative

The pathology report was requested, but not received.

• Brand Name: ZIP INTERSPINOUS FUSION SYSTEM
• Type of Device: INTERSPINOUS FUSION DEVICE
• Manufacturer (Section D): AURORA SPINE, INC; carlsbad CA
• Manufacturer Contact: mike thompson, dir ; 1920 palomar point way; carlsbad, CA 92008 ; 7604242004
• MDR Report Key: 4435681
• MDR Text Key: 5421401
• Report Number: 3010326971-2014-00001
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 001-010-S-ZIP
• Device Catalogue Number: 001-010-S-ZIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR