MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. IRIX-A LUMBAR INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number T080-0100-4

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

A visual assessment of the returned complaint rongeur showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The two actuating rails of the instrument had wear marks present from use, and the distal cutting surfaces were bent out of alignment.The top cutting surface bent laterally approximately 30°.A functionality assessment was not performed due to the damaged condition of the returned system rongeur, which was removed from distributable inventory.A dhr review was performed for the complaint 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 2/03/2016.A system rongeur may be bent when clamped on a portion of bone if there was excessive force applied to the instrument handle.It may also be possible that the rongeur could be bent when clamped on a portion of bone if the instrument handle was rotated while engaged with patient bone.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.

Event Description

The manufacturer was made aware of a product complaint on 11/08/2022.It was reported that a system rongeur was bent during a surgical procedure on (b)(6) 2022.There were no known patient complications associated with this complaint.An alternate available instrument was used to successfully complete the procedure.A return authorization number was issued for return of the complaint instrument, which was received at the manufacturer for complaint assessment on 11/18/2022.

• Brand Name: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
• Type of Device: 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: 15929069
• MDR Text Key: 308188442
• Report Number: 3005031160-2022-00038
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: M697T080010040
• UDI-Public: M697T080010041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171567
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T080-0100-4
• Device Lot Number: XS157431D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female