ZIP INTERSPINOUS FUSION SYSTEM * 108-02610-0810

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-29 for ZIP INTERSPINOUS FUSION SYSTEM * 108-02610-0810 manufactured by Aurora Spine, Inc..

Event Text Entries

[5497909] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4486492
• MDR Report Key: 4486492
• Date Received: 2015-01-29
• Date of Report: 2015-01-29
• Date of Event: 2015-01-21
• Report Date: 2015-01-29
• Date Reported to FDA: 2015-01-29
• Date Reported to Mfgr: 2015-02-05
• Date Added to Maude: 2015-02-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ZIP INTERSPINOUS FUSION SYSTEM
• Generic Name: SPINOUS PROCESS PLATE, SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Product Code: PEK
• Date Received: 2015-01-29
• Model Number: *
• Catalog Number: 108-02610-0810
• Lot Number: 1164-31
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AURORA SPINE, INC.
• Manufacturer Address: 1920 PALOMAR POINT WAY CARLSBAD CA 92008 US 92008

Device Sequence Number: 2

• Brand Name: PEEK SPACER INTRODUCER HANDLE
• Generic Name: SPINOUS PROCESS PLATE, SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Product Code: PEK
• Date Received: 2015-01-29
• Model Number: *
• Catalog Number: 108-02610-0810
• Lot Number: 125-22
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: AURORA SPINE, INC.
• Manufacturer Address: 1920 PALOMAR POINT WAY CARLSBAD CA 92008 US 92008

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-01-29