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 when the inserter and implant was being manipulated for placement, one of the handles of the inserter broke from the body of the instrument.The implant had already been placed through the opening prepared in the interspinous space when the malfunction occurred.No further placement or manipulation was required.There were no known patient complications.A visual inspection of the device confirmed the complainant's description of the damage.A dhr review was performed and the device met all required specifications prior to being released to distribution.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 and ratchet allow, the handle of the inserter may break.
Event or Problem Description
The complainant reported that when the inserter and implant was being manipulated for placement, one of the handles of the inserter broke from the body of the instrument.The implant had already been placed through the opening prepared in the interspinous space when the malfunction occurred.No further placement or manipulation was required.There were no known patient complications.

• 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: 7843688
• Report Number: 3005031160-2018-00025
• Device Sequence Number: 1155858
• Product Code: PEK
• UDI-Device Identifier: M697X06003181
• UDI-Public: M697X06003181
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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: 08/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 09/04/2018
• 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