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

Model Number	N60000160
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 the distal tip of a screw driver broke when the final screw was being tightened to secure a cervical plate.There were no known patient complications associated with this event.A visual assessment of the returned driver confirmed the complainant's report, the distal tip of the driver was broken.The distal portion of the retention arm intended to secure the screw was also broken.Excessive force applied to the driver may result in a misshaped or broken tip.Patients with unusually hard bones may require additional steps in the surgical procedure.The surgical technique guide states "for unusually hard bone, a 4mm threaded tap is provided." dense bone creates increased resistance to the instruments being used.This increased resistance may contribute to the distal tip of the driver breaking.It is possible that the placement of the final screw was in an area of increased density and could have contributed to the distal tip of the driver breaking.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to release of the batch.
Event or Problem Description
The complainant reported that the distal tip of a screw driver broke when the final screw was being tightened to secure a cervical plate.There were no known patient complications associated with this event.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8312064
• Report Number: 3005031160-2019-00006
• Device Sequence Number: 2138438
• 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): 02/05/2019

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: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/06/2019
• 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