MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. 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)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received notification on 7/06/2022 of an implant inserter that malfunctioned during a procedure.It was reported that while impacting the inserter with a mallet, a handle t-pin fell off the implant inserter.There were no known patient complications associated with this complaint.The surgical procedure was successfully completed with an alternate available instrument.The complaint instrument was received on 7/07/2022 at the manufacturer for complaint assessment.
Additional Manufacturer Narrative
A visual assessment of the returned complaint inserter showed an instrument with repeated use, as identified by worn laser markings and surface scratches.There were impact marks present on the proximal end of the inserter, and one of the handle t-pins was fractured from the body of the inserter.A functionality assessment was not performed due to the damaged condition of the returned inserter, which was removed from distributable inventory.A dhr review was performed for the returned device lot and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 5/21/2013.The root cause of this complaint cannot be reliably determined.The system inserter is intended to be impacted on the proximal end for implant placement.The complaint investigation suggests the possibility that the handle t-pin of the inserter was inadvertently impacted during a surgical procedure, which resulted in the instrument malfunction.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.

• Brand Name: CALIX LUMBAR SPINAL IMPLANT SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 15138474
• Report Number: 3005031160-2022-00023
• Device Sequence Number: 5646786
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

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: 838714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown