MAUDE Adverse Event Report: AURORA SPINE ZIP ULTRA 16MM X 45MM; ZIP ULTRA MIS INTERSPINOUS FUSION SYSTEM

Model Number 100-016-045

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Mdr required as the failure is a reportable malfunction.Recurrence could cause or contribute to a serious injury because of the possibility of metal edges puncturing the spinal dura.Although it is a rare complication, the dura may get injured or tear during any spinal surgery resulting in the leakage of cerebrospinal fluid (csf), which normally surrounds the brain and spinal cord.This leakage commonly results in severe headaches and nausea, however the effects of a spinal cord injury can range from transient deficits to more serious complications such as paralysis or bladder and bowel dysfunction.Design failure mode and effects analysis is required and has been performed within product risk documentation.Lot history for 4002-6 has been reviewed and no abnormal or nonconforming specifications were observed within the device history record.Receiving activities for lot #4002-6 reviewed include the following.Visual inspection: conforms per (b)(4) and (b)(4).Acceptance activities:conforms per supplier certificate.Dimension inspection:conforms per supplier certificate - functional.Inspection:conforms per fit against pn 100-016-045 lot#1036-3.Anodization: conforms per limit sample.Laser-marking: conforms per (b)(4) and (b)(4).Packaging /labeling: conforms per (b)(4).Simulation of mode of failure determined the failure was not possible when following surgical technique (compressing on both sets of spikes at the same time with the zip compressor large, model 100-303).Deviation from surgical technique (by compressing on a single set of spikes) consistently reproduced the described failure.

Event Description

On (b)(6) 2021 a physician reported that the zip device derailed from itself ventrally during a lumbar fusion.The physician stated metal edges remained implanted in the patient pointing towards the dura.

Manufacturer Narrative

Mdr required as the failure is a reportable malfunction.Recurrence could cause or contribute to a serious injury because of the possibility of metal edges puncturing the spinal dura.Design failure mode and effects analysis is required and has been performed within product risk documentation.Lot history for 4002-6 has been reviewed and no abnormal or nonconforming specifications were observed within the device history record.Receiving activities for lot #4002-6 reviewed include the following visual inspection: conforms per wi-100101 and wi-100102.Acceptance activities: conforms per supplier certificate.Dimension inspection: conforms per supplier certificate - functional.Inspection: conforms per fit against pn 100-016-045 lot#1036-3.- anodization: conforms per limit sample.Laser-marking: conforms per wi-100101 and wi-100102 - packaging /labeling: conforms per f100105.Simulation of mode of failure determined the failure was not possible when following surgical technique (compressing on both sets of spikes at the same time with the zip compressor large, model 100-303).Deviation from surgical technique (by compressing on a single set of spikes) consistently reproduced the described failure.Simulation of mode of failure determined the failure was not possible when following surgical technique (compressing on both sets of spikes at the same time with the zip compressor large, model 100-303).Deviation from surgical technique (by compressing on a single set of spikes) consistently reproduced the described failure.

• Brand Name: ZIP ULTRA 16MM X 45MM
• Type of Device: ZIP ULTRA MIS INTERSPINOUS FUSION SYSTEM
• Manufacturer (Section D): AURORA SPINE; 1930 palomar point way; ste 103; carlsbad CA 92008
• MDR Report Key: 11606464
• MDR Text Key: 244975831
• Report Number: 3010326971-2021-00001
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: B521001016ZIP0
• UDI-Public: B521001016ZIP0
• Combination Product (y/n): N
• PMA/PMN Number: K133091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100-016-045
• Device Catalogue Number: 001016ZIP
• Device Lot Number: 4002-6
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1