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

Model Number 001-14-S-ZIP

Device Problems Bent (1059); Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/15/2014

Event Type  Injury  

Event Description

During an ultra zip case, while compressing the zip implant, the legs of zip both bent and broke and in doing so also the pt's spinous process.The surgeon did not pursue trying to find another implant.The pt was eventually fused in-situ and the surgeon may eventually decided to go back and stabilize with other instrumentation if needed.

Manufacturer Narrative

The distributor contact explained that during the surgery, the surgeon did not use the large compressor per the surgical technique guide provided.The surgeon kept the ligament, but broke the zip device first and then the spinous process.A request for follow up was sent to the surgeon.The surgeon responded that inserting the zip implant was smooth, but then he said he does not want to talk about this right now.The surgeon removed the zip implant and closed the pt.A conference call is set up to discuss this further.

• Brand Name: ZIP MIS INTERSPINOUS FUSION SYSTEM
• Type of Device: INTERSPINOUS FUSION DEVICE
• Manufacturer (Section D): AURORA SPINE; carlsbad CA
• Manufacturer Contact: mike thompson, dir, ra/qa ; 1920 palomar point way; carlsbad, CA 92008-0000 ; 6764242004
• MDR Report Key: 4447084
• MDR Text Key: 5316022
• Report Number: 3010326971-2014-00002
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140715
• 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: 01/13/2015

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 Expiration Date: 03/10/2016
• Device Model Number: 001-14-S-ZIP
• Device Catalogue Number: 001-014-S-ZIP
• Device Lot Number: 130049-4
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 62 YR