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

Model Number T073-0500-55-DL

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The manufacturer was made aware of an instrument malfunction on (b)(6) 2022.It was reported that a system tap was identified as broken and requested to be replaced.A return authorization was issued for return of the complaint instrument, which was not received at the manufacturer for complaint assessment.Five attempts to have the complaint instrument returned for assessment and final disposition were unsuccessful.

Manufacturer Narrative

Visual and functionality assessments could not be performed due to the instrument not being received by the manufacturer.A dhr review could not be performed due to the lot number of the device not being available.The root cause of this malfunction cannot be reliably determined with the information provided.There have not been any other complaints 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: 16098537
• MDR Text Key: 308487941
• Report Number: 3005031160-2022-00043
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: M697T073050055DL1
• UDI-Public: M697T073050055DL1
• 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: 01/04/2023

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
• Device Operator: Health Professional
• Device Model Number: T073-0500-55-DL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/04/2023
• 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