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

Model Number	X067-0466
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that following use of a tap, it was identified that the tap was broken.The broken portion of the tap was recovered and there was an additional tap available to complete the surgery.There were no reported patient complications.The complaint device was not returned for complaint assessment, it was discarded at the hospital.Visual and functional assessments could not be performed.A dhr review was performed for lot# 4640 and there were no manufacturing anomalies identified.The device met all required specifications prior to being initially released on 11/11/2013.It may be possible that the tap could break if the tap or associated tap guide was inadvertently shifted while in use.If the tap or tap guide was shifted laterally while in use, it could concentrate applied force to the portion of the tap shaft with minimal material, resulting in an instrument malfunction.
Event or Problem Description
The complainant reported that following use of a tap, it was identified that the tap was broken.The broken portion of the tap was recovered and there was an additional tap available to complete the surgery.There were no reported 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: 9501113
• Report Number: 3005031160-2019-00051
• Device Sequence Number: 1542621
• Product Code: HWX
• UDI-Device Identifier: M697X06704661
• UDI-Public: M697X06704661
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: X067-0466
• Device Lot Number: 4640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/20/2019
• 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