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

Model Number	T073-1200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant requested a rod reducer be replaced.When performing reduction, the blue handle was placed on the reducer and the reducing wheel broke off.A second rod reducer was available in the instruments set and was used to complete the procedure.There were no reported patient complications.A visual assessment of the rod reducer confirmed that the gear knob was broken from the instrument.There was extensive damage to the teeth of the pinion gear identified.The pinion gear was unable to be rotated.A dhf review was performed and the instrument was determined to be suitable for distribution.A gear knob could be broken if excessive force were applied to the knob.The complainant reported that the handle extender was being used when the rod reducer broke.The handle extender increases applied leverage and can be used as necessary to aid in rod reduction.If the handle extender attached to the gear knob had rotational force applied while the rod reducer was stuck in a fixed position, it may cause the gear knob to break from the instrument.It may be possible that the gear shaft was bent and not allowing the pinion gear to rotate as intended for proper rod reduction.
Event or Problem Description
The complainant requested a rod reducer be replaced.When performing reduction, the blue handle was placed on the reducer and the reducing wheel broke off.A second rod reducer was available in the instruments set and was used to complete the procedure.There were no reported patient complications.

• Brand Name: XPRESS MINIAMALLY INVASIVE 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: 8756197
• Report Number: 3005031160-2019-00030
• Device Sequence Number: 1591360
• Product Code: MNI
• UDI-Device Identifier: M697T07312001
• UDI-Public: M697T07312001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152132
• 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): 07/02/2019

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: T073-1200
• Device Lot Number: 25095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/02/2019
• 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