MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. XSPAN LAMINOPLASTY FIXATION SYSTEM; ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Model Number	T085-0010
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional assessments could not be performed due to the complaint screwdrivers not being received at the manufacturer for complaint assessment.Dhr reviews could not be performed due to the lot number of the complaint screwdrivers not being available.If/or when there is relevant complaint incident information available, the complaint investigation and any associated regulatory reporting will be updated.There have not been any other complaints of similar nature for this instrument 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 a product complaint on 2/15/2023.It was reported that the distal hex tip of two system screwdrivers malfunctioned during a surgical procedure and were requested to be replaced.A return authorization was issued for return of the complaint instruments, which as of 3/08/2023 have not been received at the manufacturer for complaint assessment.No additional information was initially available, and requests for relevant compliant incident information and return of the complaint instruments were made on 2/15/2023, 2/21/2023, 2/27/2023, 3/02/2023, 3/06/2023, and 3/07/2023.

• Brand Name: XSPAN LAMINOPLASTY FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
• 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: 16518745
• Report Number: 3005031160-2023-00005
• Device Sequence Number: 11588680
• Product Code: HXX
• UDI-Device Identifier: M697T08500101
• UDI-Public: M697T08500101
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160114
• 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): 03/09/2023

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: T085-0010
• 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: 02/15/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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