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

Model Number	05-PA-65-50
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted on 01/08/2026 to report an issue with a mis screw.It was reported that during a posterior fusion at l3-l5, during final tightening of the last screw in a construct, the tulip of the screw dissociated from the shank.Since the other screws in the construct were final tightened and the screw with the dissociated tulip was not at either end of the construct, the dissociated tulip and screw shank were left in place.Lateral x-ray images provided by the complainant showed 6 implanted screws connected by two rods, one of the screws had its tulip dissociated from the shank of the screw.The dissociated tulip of the screw remained seated in place on the implanted rod.The screw with the dissociated tulip was the middle screw in a series of three.The shank of the screw with the dissociated tulip appeared to be seated further into the patient's bone than the other screws used for fixation.Additionally, unknown intervertebral implants appear in between the levels of fixation.
Additional Manufacturer Narrative
The complainant was not able to return the complaint screw or any components associated with the reported issue as they remain implanted in the patient.The complainant was also not able to provide a lot number for the reported complaint screw.There were no reported patient complications associated with this complaint.It was reported that the procedure was stage two of the case.Stage one was a lateral oblique procedure at l3-5 and no complications were reported.The complainant stated that the dissociation occurred during stage 2, a posterior fusion at l3 - l5 and that the issue was discovered through x-ray.Lateral x-ray images provided by the complainant showed 6 implanted screws connected by two rods, one of the screws had its tulip dissociated from the shank of the screw.The dissociated tulip of the screw remained seated in place on the implanted rod.The screw with the dissociated tulip was the middle screw in a series of three.The superior and inferior screws on either side of the complaint screw appeared undamaged and properly seated.The shank of the screw with the dissociated tulip appeared to be seated further into the patient's bone than the other screws used for fixation.Additionally, unknown intervertebral implants appear in-between the levels of fixation.A dhr review was not performed for the device because the complainant did not provide a lot number for the complaint screw.The root cause of this complaint is exposure to extreme force.Imaging provided by the complainant shows that the superior and inferior screws on either side of the screw with the dissociated tulip were more proud.The imaging also appeared to show that the shank of the screw with the dissociated tulip was bottomed out into the pedicle.It may be possible that the tulip impinged on the patient's anatomy and that could have somehow forced the head off the shank prior to tightening, but not enough that is was noticeable until the rod was locked onto it, forcing it off the rest of the way.The surgical technique guide states, "to maintain the polyaxial characteristics of the pedicle screw, avoid bottoming and/or impinging the tulip head against bony elements.Limited polyaxial motion may increase stresses to the screw and screw extension when leverage forces are applied." the surgical technique guide also states, "excessive leverage forces may increase the risk for premature extension breakage, tulip head dissociation, screw fracture, pedicle fracture and/or screw pullout." there have been two complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for mis screws that are reported to have the tulip dissociate from the shank of the screw and will perform complaint investigations as appropriate.

• Brand Name: STREAMLINE MIS SPINAL FIXATION SYSTEM
• Common Device Name: SCREW
• 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 ; 4069245878
• MDR Report Key: 24283672
• Report Number: 3005031160-2026-00002
• Device Sequence Number: 8319063
• Product Code: NKB
• UDI-Device Identifier: 00191083019604
• UDI-Public: 00191083019604
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 05-PA-65-50
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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