MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. COFIX SSYTEM; SPINOUS PROCESS PLATE

Model Number RQI00010

Device Problem Material Fragmentation (1261)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

Visual and functional inspections were not performed due to the implant fixation screw not being available for inspection.A dhr review was not performed due to manufacturing records not being available to review as part of the complaint investigation.The risk analysis fmea was reviewed which included "broken or damaged screw or sleeve during implantation", with "misalignment of screw ans [sic] sleeve during tightening" as a potential cause of hazard.The risk was mitigated by designing a special lateral screw inserter, and the risk/benefit ratio was recorded as "remaining risk is acceptable when weighted against the benefits." it may be possible for a system fixation screw to break if excessive rotational force was applied while tightening, or if there was misalignment of the screw and sleeve during tightening.It could be possible to apply excessive rotational force to the system fixation screw if the screw and sleeve were rotated beyond what is required to secure the implant in its final location.Misalignment of the screw and sleeve could allow for cross-threading when engaged and tightened.A cross-threaded screw and sleeve may seize, and additional force applied may result in the reported implant malfunction.Correct alignment of the screw and sleeve of the fixation screw must be achieved for appropriate engagement.A special lateral screw inserter was designed to aid in appropriate alignment of the screw and sleeve prior to engagement and rotation.The root cause of this complaint cannot be reliably determined.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.

Event Description

The manufacturer was made aware of a product complaint on (b)(6) 2023.It was reported that a fixation screw from a system implant fractured while being final tightened for implant placement.There were no known patient complications or delay in treatment associated with this complaint.An alternate available fixation screw was used to successfully complete the surgical procedure.

• Brand Name: COFIX SSYTEM
• Type of Device: SPINOUS PROCESS PLATE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 17961975
• MDR Text Key: 326359092
• Report Number: 3005031160-2023-00018
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: 04260148898242
• UDI-Public: 04260148898242
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2023

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 Operator: Health Professional
• Device Model Number: RQI00010
• Device Lot Number: 2021001856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR
• Patient Sex: Female