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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 X060-0320
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant reported that the distal tip of the screwdriver broke while removing a crosslink from a previous surgery.There were no known patient complications.The screw screwdriver was not returned for complaint assessment.The driver reported to have been used to remove the crosslink is not intended to be used for this function.The lot number for the complaint screwdriver was not reported to the company, a dhr review could not be performed.
 
Event or Problem Description
The complainant reported that the distal tip of the screwdriver broke while removing a crosslink from a previous surgery.There were no known patient complications.
 
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Brand Name
AXLE INTERSPINOUS FUSION SYSTEM
Common Device Name
INTERSPINOUS PROCESS FIXATION SYSTEM
Manufacturer (Section D)
X-SPINE SYSTEMS, INC.
664 cruiser lane
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MDR Report Key8092204
Report Number3005031160-2018-00033
Device Sequence Number19197160
Product Code HXX
UDI-Device IdentifierM697X06003201
UDI-PublicM697X06003201
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K130438
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/20/2018
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 NumberX060-0320
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2018
Initial Report FDA Received Date11/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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