MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. SPIDER CERVICAL PLATING SYSTEM; SCREWDRIVER

Model Number	N60000160
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was notified of a product complaint on 04/24/2025.It was reported that a system screwdriver was requested to be replaced.Detalis from the complainant were provided on 04/29/2025, which informed the manufacturer that the system screwdriver was requested to be replaced due it breaking during surgery.There were no reported patient complications or delays in procedure associated with this complaint.A return authorization was issued for the return of the complaint instrument, which was received at the manufacturer for assessment on 04/29/2025.
Additional Manufacturer Narrative
The manufacturer was made aware of this complaint on 04/24/2025 despite the surgery happening on (b)(6) 2025.Additionally, the complainant did not provide any details as to what the complaint was until 04/29/2025.Therefore, the complaint was not assessed as reportable until 04/29/2025 and will be submitted 30 days from 04/29/2025.The visual assessment showed an instrument with surface scratches and as reported, the distal tip of the system screwdrivers distal tip was fractured and missing from the device.A functionality assessment was unable to be performed due to the damaged condition of the screwdriver, which was removed from distributable inventory.A dhr review was performed for the instrument lot and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.The system screwdriver has been available for distribution since 07/18/2016.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: SCREWDRIVER
• 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 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln.; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 22097721
• Report Number: 3005031160-2025-00019
• Device Sequence Number: 15314857
• Product Code: LXH
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K170224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: N60000160
• Device Lot Number: 7396-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2016
• 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
• Patient Age: 52 YR
• Patient Sex: Unknown