MAUDE Adverse Event Report: AURORA SPINE, INC. ZIP LP; ZIP LP, 16MM X 45MM

Model Number 103-016-045

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Spinal Column Injury (2081)

Event Date 10/26/2022

Event Type  Injury  

Event Description

A spinal implant dislodged in a patient.Dr.Coccaro performed a revision of the spinal implant surgery which was required for explantation of the medical device.

• Brand Name: ZIP LP
• Type of Device: ZIP LP, 16MM X 45MM
• Manufacturer (Section D): AURORA SPINE, INC.; 1930 palomar point way; suite 103; carlsbad CA 92008
• Manufacturer (Section G): AURORA SPINE, INC.; 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: 16840363
• MDR Text Key: 314260733
• Report Number: 3010326971-2023-00002
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2023

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: 103-016-045
• Device Catalogue Number: 103-016-045
• Device Lot Number: 5969-1
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female