MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC CORTERA SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	150100-65045
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned screw showed minimal surface scratches.The tulip appears to have been swaged properly and it does not rotate which suggests that the tulip is in the correct position.Testing with a gage showed that the gage would not thread onto the screw.Further investigation showed the screw threading was damaged.A dhr review was performed for the implant lot which met all required specifications prior to being released to distributable inventory.Due to the vendor inspection requirements and the ability to attach the screwdriver, it is likely that the damaged screw threading was caused by unintended user error or force.This lot has been available for distribution since 06/28/2024, resulting in an approximate field life of three months.Based on the information reviewed, the root cause of this event was determined to be unintended user error.There have been zero other complaints of similar nature for this implant in the past 12 months.The manufacturer will continue to monitor the field for complaints of similar screw deficiencies.
Event or Problem Description
It was reported that the patient underwent a posterior spinal fixation surgery involving the pedicle screw system.During the surgery it was reported that the surgeon had difficulty with sitting the rod into the screw.No patient complications were reported.No additional information is available.

• Brand Name: CORTERA SPINAL FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln; belgrade 59714
• MDR Report Key: 20246892
• Report Number: 3005031160-2024-00032
• Device Sequence Number: 15281972
• Product Code: NKB
• UDI-Device Identifier: 00810076563190
• UDI-Public: 00810076563190
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K221403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: 150100-65045
• Device Lot Number: AP24000082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown