MAUDE Adverse Event Report: XTANT MEDICAL CERTEX SPINAL FIXATION SYSTEM; SPINAL IMPLANTS

Model Number	X067-0470
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functionality assessments could not be performed due to the complaint instrument not being returned to the company.A dhr review could not be performed due to the lot number of the complaint instrument not being available.It is unknown when and how the system counter torque sleeve was broken.Repeated attempts to collect complaint incident information and return of the complaint instrument were unsuccessful.There have not been any other complaints of similar nature for either complaint instrument in the past 12 months.The company will continue to monitor this device for complaints from the field.
Event or Problem Description
The company received notification on 7/13/2021 of a system counter torque sleeve that was requested to be replaced due to an instrument malfunction.A return authorization number was issued for return of the complaint instrument, which was not received at the company for complaint assessment.No other information regarding the surgical procedure or instrument deficiency was provided.Repeated attempts to collect complaint incident information and return of the complaint instrument were unsuccessful.
Event or Problem Description
The company received additional communication from the complainant on (b)(6) 2021 in regards to the reported instrument malfunction and surgical outcome.The complainant confirmed that the instrument malfunction did not result in any patient complications or delay in treatment.The procedure was successfully completed with the complaint instrument without incident.This follow-up report is associated with mfr 3005031160-2021-00015.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL IMPLANTS
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12298520
• Report Number: 3005031160-2021-00015
• Device Sequence Number: 14750015
• Product Code: KWP
• UDI-Device Identifier: M697X06704701
• UDI-Public: M697X06704701
• Combination Product (Y/N): N
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other