MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. AXLE INTERSPINOUS FUSION SYSTEM; INTERSPINOUS PROCESS FIXATION SYSTEM

Model Number	X060-0318
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that a cross bar plate grip-lock inserter broke.The complainant confirmed that there were no patient complications associated with the incident.A visual inspection of the device confirmed the complainant's description of the damage.A dhr was performed and the device met all required specifications prior to being released to distribution.The inserter ratchet is intended to hold the inserter in a fixed position with the implant loaded.If the handles are compressed further than the implant and ratchet allow, the distal end of he left handle, holding the implant may break.The inserter malfunction could be replicated if excess force was applied to the handles of the inserter.The inserter ratchet is intended to hold the inserter in a fixed position with the implant loaded.If the handles are compressed further than the implant ratchet allows, the handle of the inserter may break.
Event or Problem Description
The complainant reported that a cross bar plate grip-lock inserter broke.The complainant confirmed that there were no patient complications associated with the incident.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: INTERSPINOUS PROCESS FIXATION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7877290
• Report Number: 3005031160-2018-00027
• Device Sequence Number: 16629193
• Product Code: PEK
• UDI-Device Identifier: M697X06003181
• UDI-Public: M697X06003181
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• 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): 09/14/2018

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: X060-0318
• Device Lot Number: I8365-0000R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/14/2018
• 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