MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	X022-0161
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
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 surgeon was performing the final lock and the driver broke inside the fortex locking cap.The surgeon was able to remove the bit that broke off from the locking cap and performed the final lock with a normal locking driver.The complainant confirmed that there was no harm done to the patient.The device was not returned for complaint assessment, however, the complainant provided photos.The photos of the device depict the damage as described by the complainant.The dhr for the device was reviewed and there were no manufacturing anomalies identified.The device met all required specifications prior to being released for distribution.As of 04/19/2018, the device has not been received by the manufacturer for complaint investigation.
Event or Problem Description
The complainant reported that the sugeon was performing the final lock and the driver broke inside the fortex locking cap.The surgeon was able to remove the bit that broke off from the locking cap and performed the final lock with a normal locking driver.The complainant confirmed that there was no harm done to the patient.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7444611
• Report Number: 3005031160-2018-00009
• Device Sequence Number: 1264272
• Product Code: HXX
• UDI-Device Identifier: M697X02201611
• UDI-Public: M697X02201611
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K120832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• 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: X022-0161
• Device Lot Number: 115901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2018
• 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