MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. STREAMLINE MIS SPINAL FIXATION SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	05-PA-75-40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The preliminary inspection performed showed a single system pedicle screw connected to an unknown system rod.The locking cap of the system pedicle screw was present, and the shank of the screw was fractured on the proximal end near the tulip of the screw implant.The inserter end of the system rod was damaged, presumably from removal during the revision procedure.A dhr review was performed for complaint lot# 317906 and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 8/14/2018.Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone.The system ifu appropriately lists, "device component fracture" as a possible risk with implantation of the system.The ifu also states, "no implant and screw system can withstand the forces of sudden dynamic loads such as falls or other accidents." the root cause of this complaint cannot be reliably determined.There have not been any other complaints of similar nature for post-operative pedicle screw malfunctions for this product family in the past 12 months.The manufacturer will continue to monitor the field for complaints of post-operative implant screw malfunctions.
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2024.It was reported that during a six-month surgical follow-up a system pedicle screw was identified as having malfunctioned.An xray image was provided of the reported implant deficiency, which appeared to show the shank of the pedicle screw was broken near the implant screw tulip.The broken pedicle screw and rod construct was removed during a revision procedure and replaced without any known incident.

• Brand Name: STREAMLINE MIS SPINAL FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade ; 4069245878
• MDR Report Key: 19088836
• Report Number: 3005031160-2024-00008
• Device Sequence Number: 20611168
• Product Code: NKB
• UDI-Device Identifier: 00846468052515
• UDI-Public: 00846468052515
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K192396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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
• Device Model Number: 05-PA-75-40
• Device Lot Number: 317906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2018
• 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 Sex: Unknown