MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CALIX-C CERVICAL INTERBODY SPACER; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	C003-0027
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received notification of an instrument malfunction on (b)(6) 2022.It was reported that a cervical 6mm rasp malfunctioned during a surgical procedure.There were no know patient complications associated with this complaint and the procedure was successfully completed.The complaint instrument was returned to the manufacturer on 2/23/2022 for complaint assessment.
Additional Manufacturer Narrative
A visual assessment of the returned complaint rasp showed an instrument with repeated use, as identified by worn laser markings, surface scratches, and damaged peaks of the rasp portion.The rasp head was fractured from the instrument handle, and the distal tab portion of the handle was bent in a manner that suggests it was shifted superior or inferior while the rasp head maintained a fixed position.A functionality assessment was not performed due to the damaged condition of the complaint instrument, which was removed from distributable inventory.A dhr review was performed for the cervical rasp complaint lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 2/04/2020.There have been two other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the complaint device for complaints from the field.

• Brand Name: CALIX-C CERVICAL INTERBODY SPACER
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 13715444
• Report Number: 3005031160-2022-00015
• Device Sequence Number: 6286909
• Product Code: ODP
• UDI-Device Identifier: M697C00300271
• UDI-Public: M697C00300271
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171075
• 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): 03/09/2022

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: C003-0027
• Device Lot Number: SPE1987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown