MAUDE Adverse Event Report: XTANT MEDICAL CALIX LUMBAR SPINAL IMPLANT SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	X034-0015
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was performed for the returned device lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 12/04/2012.The system inserter is intended to be impacted on the proximal end for implant placement.The root cause of this complaint is the t-handle of the inserter was inadvertently impacted during a surgical procedure, which resulted in the instrument malfunction.
Event or Problem Description
The company received notification on 8/31/2021 of an implant inserter that malfunctioned during a procedure on an unknown date.It was reported that while impacting the inserter with a mallet, the physician inadvertently impacted the inserter t-handle.The impact to the inserter t-handle resulted in an instrument malfunction.There were no known patient complications associated with this complaint.The surgical procedure was successfully completed with the complaint instrument.

• Brand Name: CALIX LUMBAR SPINAL IMPLANT SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12537470
• Report Number: 3005031160-2021-00019
• Device Sequence Number: 1335403
• Product Code: MAX
• UDI-Device Identifier: M697X03400151
• UDI-Public: M697X03400151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170119
• 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): 09/27/2021

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: X034-0015
• Device Lot Number: 836590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/27/2021
• 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