MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number X010-0151

Device Problem Break (1069)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

The manufacturer was made aware of a product complaint on 11/28/2023.It was reported that a system 5.5mm cannulated tap malfunctioned while being used in a surgical procedure.There were no known patient complications associated with this complaint, an alternate available instrument was used to successfully complete the procedure.An rma# was issued for return of the complaint instrument, which was not available to be returned to the manufacturer for assessment due to being discarded at the surgical facility.

Manufacturer Narrative

Visual and functional assessments could not be performed due to the complaint instrument not being received at the manufacturer for complaint assessment.A dhr review could not be performed due to the lot number of the complaint instrument not being available.It may be possible for a system 5.5mm tap to break when preparing patient bone if it was inadvertently shifted out of alignment while tapping the drilled patient bone.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: XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• 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: 18404973
• MDR Text Key: 331548849
• Report Number: 3005031160-2023-00027
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: M697X01001511
• UDI-Public: M697X01001511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152132
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X010-0151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female