MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. SPIDER CERVICAL PLATING SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	N60000160
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the distal tip of the screwdriver broke during a surgery.There were no known patient complications.The screwdriver was returned for complaint assessment, where the described damage was confirmed.The distal tip of the screwdriver and spring were broken.Functionality testing could not be performed due to the damage.The distal tip of the complaint screwdriver could have been damaged if excessive torque was applied to the driver, or a lateral force applied to the driver while seated in a screw.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distribution.
Event or Problem Description
The complainant reported that the distal tip of the screwdriver broke during a surgery.There were no known patient complications.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8400901
• Report Number: 3005031160-2019-00011
• Device Sequence Number: 16597111
• Product Code: HXX
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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: N60000160
• Device Lot Number: 7396-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/07/2019
• 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