MAUDE Adverse Event Report: XTANT MEDICAL AXLE INTERSPINOUS FUSION SYSTEM SPINOUS PROCESS PLATE

Model Number X060-1520

Device Problem Material Fragmentation (1261)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The system implant plate is secured to the inserter/compressor by tightening a set screw on the instrument. It may be possible to fracture the distal tip of an inserter/compressor if excessive force was applied to the interface between the inserter/compressor and implant plate by over tightening the set screw. The root cause of this complaint cannot be reliably determined due to a lack of available information. The complaint investigation suggests the possibility that the set screw that secures the implant plate to the inserter/compressor was over tightened, resulting in the distal portion of the instrument breaking.

Event Description

The company received notification on (b)(6) 2021 of a system inserter/compressor that was reported to malfunction when loading an implant onto the instrument. Five attempts to gather relevant complaint incident information and request the instrument to be returned were made, and no additional information was provided. There were no known patient complications reported as part of this instrument complaint. The instrument has not been received at the manufacturer for complaint assessment.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Type of Device: SPINOUS PROCESS PLATE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 12510841
• MDR Text Key: 272680150
• Report Number: 3005031160-2021-00018
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: X060-1520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 09/21/2021 Patient Sequence Number: 1