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

Model Number	X085-0150-STR
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgical tray was distributed by the manufacturer to a customer on 11/10/2020 and contained all required implants that were within the specified shelf life.The implanted laminoplasty implants that were used during the procedure expired 8/22/2021.Dhr reviews were performed for the expired implant lots, and there were no manufacturing anomalies identified.The devices met all required specifications prior to being released to distributable inventory.These complaint device lots have been available for distribution since 9/23/2016.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for similar complaints.
Event or Problem Description
The manufacturer received notification on 1/04/2022 of nine implants that were implanted past expiration during a laminoplasty procedure on (b)(6) 2022.There were no known patient complications associated with this complaint.This report is associated with 3005031160-2022-00003, 3005031160-2022-00005, 3005031160-2022-00006, 3005031160-2022-00007, 3005031160-2022-00008, 3005031160-2022-00009, 3005031160-2022-00010, and 3005031160-2022-00011.

• 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: 13428115
• Report Number: 3005031160-2022-00004
• Device Sequence Number: 3992052
• Product Code: NQW
• UDI-Device Identifier: M697X0850150STR1
• UDI-Public: M697X0850150STR1
• 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
• Device Implanted Year: 2022
• 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): 02/02/2022

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 Expiration Date: 08/22/2021
• Device Model Number: X085-0150-STR
• Device Lot Number: 047596-51444
• 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: 01/04/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2016
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male