MAUDE Adverse Event Report: AURORA SPINE ZIP

Model Number UNKNOWN

Device Problem Material Separation (1562)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

Doctor relayed photograph through distributor, showing separated zip.No patient or facility information on c arm photograph.No patient information.Doctor not responding.No explant.Photograph may be cadaver.

• Brand Name: ZIP
• Type of Device: ZIP
• Manufacturer (Section D): AURORA SPINE; 1930 palmar point way; suite 103; carlsbad CA 92008
• Manufacturer (Section G): AURORA SPINE; 1930 palomar point way; suite 103; carlsbad CA 92008
• Manufacturer Contact: laszlo garamszegi ; 1930 palomar point way; suite 103; carlsbad, CA 92008
• MDR Report Key: 14605494
• MDR Text Key: 295136192
• Report Number: 3010326971-2022-00001
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 06/06/2022
• 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
• Patient Sequence Number: 1