MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CALIX SPINAL IMPLANT SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number X034-0387

Device Problem Material Fragmentation (1261)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

The manufacturer was made aware of a product complaint on 6/19/2023.It was reported that a 26mm x 10mm x 6mm x 5° plif implant malfunctioned when being placed during a procedure.There were no known patient complications or delay in treatment associated with this complaint.The malfunctioned implant was removed, and an alternate available implant was successfully utilized to complete the surgical procedure.The complaint implant was discarded at the surgical facility and not available to be returned to the manufacturer for assessment.The complainant provided photos of the complaint implant, which showed the proximal end that engages with the system inserter had fractured from the body of the implant.

Manufacturer Narrative

The complainant described the way the implant was damaged and stated, "implant was placed partially into the void and was tapped with a mallet on the t handle inserter.After a few taps the implant just fell apart.There was no twisting or non direct force applied." a dhr review was performed for implant lot and there were no manufacturing anomalies identified.The implant lot met all required specifications prior to being released to distributable inventory.The implant lot has been available for distribution since 8/22/2012.The root cause of this complaint cannot be reliably determined.The complainant provided photos of the complaint implant, which showed the proximal end that engages with the calix inserter had fractured from the body of the implant.It was reported that the implant malfunction occurred when the attached inserter was impacted with a mallet.It may be possible for an implant malfunction to occur when the attached inserter was impacted if excessive force was applied.The complaint implant has a 5° lordosis and a larger distal end.If the implant was placed into a collapsed disc space, the increased resistance may have contributed to excessive force placed on the inserter/implant interface.The system inserter has a threaded rod that engages with a matching threaded hole in the implant, which is also proximally supported by the inserter.If the distal end of the implant had resistance to being placed into the intervertebral space, it may be possible that the force could be transferred to the smaller proximal end of the implant/inserter interface and result in the observed implant malfunction.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this implant product line for complaints from the field.

• Brand Name: CALIX SPINAL IMPLANT SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT
• MDR Report Key: 17355314
• MDR Text Key: 319755437
• Report Number: 3005031160-2023-00011
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: M697X03403871
• UDI-Public: M697X03403871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X034-0387
• Device Lot Number: 039775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2012
• 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: 73 YR