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 tip of the screwdriver broke off inside the screw head.The driver broke when the screw was being tightened down, after it passed the locking arm.There are no known patient complications.A visual inspection was performed by the company confirming that the distal tip of the driver was broken as reported by the complainant.The broken tip of the driver was not returned of complaint assessment.The company made an inquiry to the complainant regarding the remaining piece.The complainant responded stating that the tip of the screwdriver "cold-fused" to the screw head and would not come off.The screwdriver showed signs of repeated use.A dhr review was performed and no manufacturing anomalies were identified and the device met the required specifications.The damage to the screwdriver may have been caused by over-tightening the screw in combination with fatigue of the device.
Event or Problem Description
The complainant reported that the tip of the screwdriver broke off inside the screwhead.The driver broke when the screw was being tightened down, after it passed the locking arm.There are no known patient complications.

• 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: 7381952
• Report Number: 3005031160-2018-00005
• Device Sequence Number: 13484794
• Product Code: HXX
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• PMA/510(K) Number: K170224
• 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: Health Professional
• Device Model Number: N60000160
• Device Lot Number: I6081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1