MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. SPIDER CERVICAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	N60000110
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned cervical plate identified that several of the locking arms were damaged and misshaped.One superior/inferior locking arm and the two middle locking arms were bent in a manner that would not allow them to effectively retain implant screws after being placed.A functionality assessment was not performed due to the damaged condition of the returned cervical plate, which was removed from distributable inventory.A dhr review was performed for the implant complaint lot and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 9/10/2020.It is unknown how the cervical plate was damaged.The cervical plate was inspected prior to distribution from the manufacturer and was in appropriate condidtion to function as intended.It may be possible for the locking arms of a cervical plate to not lock correctly if the locking arms of the implant were damaged.The locking arms of a cervical plate could be damaged if they were impacted or otherwise misshaped during placement.It may be possible to damage the locking arms of a cervical plate during placement if the fixation pins were not oriented with flat portions medial and lateral, or if the locking arms were damaged removing the fixation pins.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.
Event or Problem Description
The manufacturer was made aware of a product complaint on 2/03/2023.It was reported that the locking arms of a cervical plate would not effectively lock implant screws and was requested to be returned to the manufacturer for assessment.An rma number was issued for return of the complaint implant, which was received at the manufacturer for assessment on 2/15/2023.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 16474039
• Report Number: 3005031160-2023-00003
• Device Sequence Number: 5119641
• Product Code: KWQ
• UDI-Device Identifier: M697N600001101
• UDI-Public: M697N600001101
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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: N60000110
• Device Lot Number: 18155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• 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 Sex: Unknown