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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. XPRESS MINIMALLY INVASIVE PEDICEL SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM

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X-SPINE SYSTEMS, INC. XPRESS MINIMALLY INVASIVE PEDICEL SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number T073-1000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2019
Event Type  Malfunction  
Manufacturer Narrative

The complainant reported that while inserting a rod, the distal tip of an inserter broke. The surgeon was able to successfully finish the surgery. There were no known patient complications. The instrument has not been received for complaint investigation. Pictures of the device depicted one of the distal hooks of the inserter broken from the instrument. A dhr review was performed. The instrument met all required specifications prior to being released to distributable inventory on 06/20/2016. A lateral force applied to the inserter while placing a rod into a pedicle screw may have caused the damage to the inserter. Application of lateral force to the inserter concentrates force to the interface between the inserter and rod.

 
Event Description

The complainant reported that while inserting a rod, the distal tip of an inserter broke. The surgeon was able to successfully finish the surgery. There was no harm to the patient.

 
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Brand NameXPRESS MINIMALLY INVASIVE PEDICEL SCREW SYSTEM
Type of DevicePEDICLE SCREW SPINAL 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 Key8471542
MDR Text Key140616434
Report Number3005031160-2019-00019
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodePO
PMA/PMN NumberK152132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 04/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberT073-1000
Device LOT NumberXS157167A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/20/2016
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: 04/01/2019 Patient Sequence Number: 1
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