MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. COFLEX INTERLAMINAR TECHNOLOGY; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number	UAT20100
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional assessments could not be performed due to the complaint instrument not being returned for assessment.A dhr review could not be performed due to the lot number of the complaint instrument not being available.The age of the complaint instrument could not be identified.The head of the system mallet is secured into the handle with an epoxy glue.It may be possible that repeated use and exposure to sterilization cycles may have contributed to the glue not maintaining adhesion as intended.Repeated impacts to the mallet as well as exposure to sterilization cycles may have contributed to the reported instrument malfunction.The root cause of this complaint cannot be reliably determined.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The manufacturer was made aware of an instrument malfunction on 6/27/2023.It was reported that the head of a system mallet fractured from the handle of an instrument while being used during a surgical procedure.There were no known patient complications or delay in treatment, an alternate available mallet from the surgical facility was utilized to successfully complete the procedure.Email inquiries were sent to the complainant for additional complaint incident information and return of the complaint instrument, which were unsuccessful.An rma number was issued for return of the complaint instrument, which as of 7/26/2023 has not been received at the manufacturer for assessment.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT
• MDR Report Key: 17410015
• Report Number: 3005031160-2023-00013
• Device Sequence Number: 20605580
• Product Code: HXL
• UDI-Device Identifier: 04260148890130
• UDI-Public: 04260148890130
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P110008
• 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): 07/27/2023

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: UAT20100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown