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U.S. Department of Health and Human Services

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

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X-SPINE SYSTEMS, INC. AXLE INTERSPINOUS FUSION SYSTEM INTERSPINOUS PROCESS FIXATION SYSTEM Back to Search Results
Model Number X060-0318
Device Problems Break (1069); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2019
Event Type  Malfunction  
Manufacturer Narrative

The complainant reported that when the surgeon pressed the grip-lock inserter to secure the implant, the inserter suddenly broke. There were no reported patient injuries or complications. A visual assessment of the returned grip-lock inserter showed an instrument with repeated use. A functionality assessment could not be performed due to the broken distal tip of the grip-lock inserter. The associated dhr was reviewed, and the device met all required specifications prior to initially being released to distributable inventory. A grip-lock inserter may become broken if excessive force were applied to the handles of the instrument, or if there were lateral force applied to the distal tip of the inserter while engaged with an implant.

 
Event Description

The complainant reported that when the surgeon pressed the grip-lock inserter to secure the implant, the inserter suddenly broke. There were no reported patient injuries or complications.

 
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Brand NameAXLE INTERSPINOUS FUSION SYSTEM
Type of DeviceINTERSPINOUS 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 Key8719641
MDR Text Key149368770
Report Number3005031160-2019-00029
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK101471
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberX060-0318
Device LOT NumberI6249R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/31/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/20/2019 Patient Sequence Number: 1
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