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

Model Number	150150-65040
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system screw showed a screw with use as identified by surface scratches on the head of the screw shank and initial threads.A dhr review was performed for the screw lot which met all required specification prior to being released to distributable inventory.It has been available for distribution since 10/13/2023, resulting in an approximate field life of one year.There have been no other complaints of similar nature for this screw in the past 12 months.The manufacturer will continue to monitor the field for complaints of system screws that have the tulip dissociate from the screw shaft.
Event or Problem Description
It was reported that the patient underwent a posterior fusion after performing a l5-1 alif on (b)(6) 2024.During the procedure, the tulip/tower of the screw dissociated from the screw shaft during insertion of the screw, possibly with boney contact nearing full seating.The screw shaft was removed, and a new screw was inserted without further issue and no noted delay in surgery.There were no known patient complications associated with this complaint.No additional information is available.

• Brand Name: CORTERA
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln.; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln; belgrade MT 59174
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln; belgrade, MT 59714
• MDR Report Key: 20360396
• Report Number: 3005031160-2024-00034
• Device Sequence Number: 12555352
• Product Code: NKB
• UDI-Device Identifier: 00840311200672
• UDI-Public: 00840311200672
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K241892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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: 150150-65040
• Device Lot Number: AP22000221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female