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

Model Number X060-0318

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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
• Type of Device: INTERSPINOUS PROCESS FIXATION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: casey ming ; 664 cruiser lane; belgrade, MT 59714 ; 4063880480
• MDR Report Key: 7877290
• MDR Text Key: 120540286
• Report Number: 3005031160-2018-00027
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: M697X06003181
• UDI-Public: M697X06003181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other