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

Model Number 05-PA-75-40

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 340699393
• Report Number: 3005031160-2024-00008
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468052515
• UDI-Public: 00846468052515
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K192396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other