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

Model Number	X060-1520
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint inserter/compressor showed an instrument with minimal use, as identified by crisp laser markings and a lack of surface scratches.The pin of the instrument distal tip was fractured where it connects with the instrument handle.A functionality assessment was not performed due to the damaged condition of the returned inserter/compressor, which was removed from distributable inventory.It may be possible that application of excessive compression force may have contributed to one of the instrument distal tips fracturing from the instrument.The instrument tip is secured into the instrument handle with a cylinder that has minor movement to allow for implant engagement and patient anatomy.It may be possible that plate angulation due to patient anatomy or over compressing the instrument may concentrate applied force to the instrument distal tip, resulting in an instrument malfunction.
Event or Problem Description
The company received notification on (b)(6) 2021 of a system inserter/compressor that malfunctioned during a surgical procedure.It was reported that one of the distal tips of the instrument fractured while compressing interspinous plates after being placed.There were no known patient complications associated with this complaint.Alternate available instruments were used to successfully complete the surgical procedure.The complaint instrument arrived at the manufacturer for assessment on 9/28/2021.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: SPINOUS PROCESS PLATE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12586780
• Report Number: 3005031160-2021-00021
• Device Sequence Number: 3067699
• Product Code: PEK
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: X060-1520
• Device Lot Number: 21179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 104