MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC CONTACT ANTERIOR LUMBAR PLATE SYSTEM; Orthopedic manual surgical instrument

Model Number	25-INSERTER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inserter was returned for evaluation and the reported event was confirmed.Signs of wear was apparent across the inserter, including worn laser markings and surface scratches.One of the distal prongs on the inserter was missing as reported.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing records for the inserter lot was performed and no manufacturing anomalies identified.The instrument lot met all required specification prior to being released to distributable inventory on 03/16/2021, resulting in an approximate field life of three years.A definitive root cause was unable to be determine with the information provided; however, it may have been related to excessive force applied to the instrument and/or wear or other damage to the instrument over time.It is unknown how many uses the instrument has undergone after release to the field.There have not been any other complaints of similar nature for the system inserter with separated components.The manufacturer will continue to monitor for reports of non-functional instruments and perform complaint investigations as appropriate.
Event or Problem Description
It was reported that a distal prong of the system inserter broke during a procedure.There were no known patient complications associated with this complaint and the surgical procedure was successfully completed by using an alternate inserter.No additional information available.

• Brand Name: CONTACT ANTERIOR LUMBAR PLATE SYSTEM
• Common Device Name: Orthopedic manual surgical instrument
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln; belgrade, MT 59714
• MDR Report Key: 20925668
• Report Number: 3005031160-2024-00043
• Device Sequence Number: 12085728
• Product Code: LXH
• UDI-Device Identifier: 00840311232857
• UDI-Public: 00840311232857
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 25-INSERTER
• Device Lot Number: 391141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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