MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CERTEX SPINAL FIXATION SYSTEM; SPINAL IMPLANTS

Model Number	X067-0470
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of an instrument malfunction on 11/04/2022.It was reported that a distal tine of a system counter torque sleeve fractured while being used during a surgical procedure on (b)(6) 2022.There were no known patient complications or delays in treatment.An alternate available instrument was used to successfully complete the procedure.A return authorization was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 11/17/2022.
Additional Manufacturer Narrative
A visual assessment of the returned complaint counter torque sleeve showed an instrument with repeated use, as identified by worn laser markings, surface scratches, and implant engagement wear marks.One of the four distal tines was fractured from the instrument as reported.A functionality assessment was not performed due to the damaged condition of the returned counter torque sleeve, 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 1/29/2016.It is unknown why one of the distal arms of the counter torque sleeve could be fractured.It may be possible that the counter torque sleeve may not have been entirely engaged with the implant construct, and the distal arm that was engaged may have fractured due to the rotational force applied.The root cause of this complaint cannot be reliably determined.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: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL IMPLANTS
• 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: 15886869
• Report Number: 3005031160-2022-00036
• Device Sequence Number: 5103422
• Product Code: NKG
• UDI-Device Identifier: M697X06704701
• UDI-Public: M697X06704701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160428
• 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): 11/30/2022

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: X067-0470
• Device Lot Number: 054003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2016
• 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 Age: 80 YR
• Patient Sex: Male