MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC STREAMLINE MIS SPINAL FIXATION SYSTEM; Thoracolumbosacral pedicle screw system

Model Number	05-PA-55-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the complainant.No device was returned for evaluation; further no photographs were provided.Operative notes and/or medical records were not provided for review of usage/technique.It was noted that due to a broken tab breaker, this process had to be done manually.The shank of the screw was able to be removed and a replacement screw was set in place.A review of manufacturing records were unable to be completed as the lot information of the product was not available.No further investigation was able to be performed at this time.A definitive root cause was unable to be determined with the information provided.The ifu for the streamline mis system states "inspect the product, including all packaging and labeling materials carefully.Do not use if the implant or packaging is damaged." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
The manufacturer was made aware of an implant malfunction on (b)(6) 2024 in which it was reported that a system pedicle screw implant disassociated during implantation.The complainant reported that a system instrument was received in damaged condition, and that removal of the pedicle screw extensions was performed manually, which resulted in the reported implant malfunction.There was an approximate 30-45 minute delay in the procedure, which was successfully completed without any further complication.No additional information available.

• Brand Name: STREAMLINE MIS SPINAL FIXATION SYSTEM
• Common Device Name: Thoracolumbosacral pedicle screw system
• 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: 20800688
• Report Number: 3005031160-2024-00039
• Device Sequence Number: 6990011
• Product Code: NKB
• UDI-Device Identifier: 00191083019512
• UDI-Public: 00191083019512
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K192396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: 05-PA-55-45
• 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: 10/31/2024
• Initial Report FDA Received Date: 11/27/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown