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

Model Number	150150-65040
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pedicle screw with dni imprinted on the screw tulip was implanted.The screw did not lock down and was removed and replaced with a clinical cortera screw.
Additional Manufacturer Narrative
The screws marked dni were inadvertently distributed by a contract manufacturer responsible for labeling, storage and distribution of certain xtant medical products.The affected screws are direct marked with dni as the lot number and may not have been manufactured in accordance with released manufacturing specifications.The affected screws were manufactured in a manner to be representative of clinical production parts regarding form and fit, but not necessarily function.The affected screws were manufactured from anodized titanium metal with the same or similar size and dimension.If the surgeon or his/her assistants do not look at the direct marked lot number or do not notice the difference in anodization color, he/she may attempt to implant the affected screws, which contribute to product risk.If the surgeon attempted to implant the affected screw(s) into a patient, the screw(s) may not perform as intended (may be difficult to start the set screw, or it may not be able to engage), which the surgeon would notice during implantation.To-date there have been two (2) complaints received involving the affected cortera spinal fixation system screws.These complaints led to the investigation and discovery of the deficiency in the devices.Xtant medical holdings, inc.Initiated a medical device recall on 08/20/2024.Xtant is conducting this recall with the knowledge of the food and drug administration's knowledge (3005031160-09/04/2024-001-r).

• Brand Name: CORTERA SPINAL FIXATION SYSTEM
• Common Device Name: SCREW
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 20206255
• Report Number: 3005031160-2024-00030
• Device Sequence Number: 7643694
• Product Code: NKB
• UDI-Device Identifier: 00810076563190
• UDI-Public: 00810076563190
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K221403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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
• Device Model Number: 150150-65040
• Device Lot Number: DNI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 150100-65045 - SCREW, POLY, SOLID, 6.5X45.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown