MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. CERTEX SPINAL FIXATION SYSTEM; SPINAL IMPLANTS

Model Number	X067-0425
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that two cross connector locking drivers were broken and requested to return the broken parts.No additional information was provided.There were no known patient complications.Attempts to collect complaint details were made on 05/24/2018, 05/29/2018, 06/04/2018, 06/12/2018, 06/13/2018, 06/14/2015, and 06/15/2018.The complainant was unable to provide sufficient details to thoroughly investigate the complaint issue.Devices from lot numbers 041044, and 054649 were returned to the company by the complainant on 05/29/2018.A visual assessment was performed, and the corresponding dhrs were reviewed.No manufacturing anomalies were identified during the dhr reviews and the parts met all required specifications prior to being released for distribution.
Event or Problem Description
The complainant reported that two cross connector locking drivers were broken and requested to return the broken parts.No additional information was provided.There were no known patient complications.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL IMPLANTS
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7622700
• Report Number: 3005031160-2018-00018
• Device Sequence Number: 13876753
• Product Code: HXX
• UDI-Device Identifier: M697X06704251
• UDI-Public: M697X06704251
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: No Information
• Device Model Number: X067-0425
• Device Lot Number: 041044, 054649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/20/2018
• 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