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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 Problem Break
Event Type  Malfunction  
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 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.

 
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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 Key7843688
Report Number3005031160-2018-00025
Device Sequence Number1
Product CodePEK
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 09/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberX060-0318
Device LOT NumberI8365-0000R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/06/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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