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U.S. Department of Health and Human Services

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

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X-SPINE SYSTEMS, INC. XPRESS MINIMALLY INVASIVE PEDICLE 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 Type  Malfunction  
Manufacturer Narrative

The complainant requested to return a serious of broken instruments for replacement. The complainant was unable to provide details regarding the incidents. There were no known patient complications associated with the malfunctions. The following mdrs are related to the receipt of this complaint. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018. The rotating rod inserter had worn laser markings and surface scratches, indicating that the instrument was used repeatedly. One of the prongs at the distal end of the instrument was bent outwards and the other was broken and not present. A dhr review was performed and the instrument met all require specifications prior to being made available for distribution on 7/15/2016. The prongs at the distal tip of a rotating rod inserter may become damaged if the instrument were moved laterally while the attached rod was engaged with a screw extension and pedicle screw construct. Lateral movement while engaged with a screw extension and pedicle screw concentrates applied force to the interface between the rotating rod inserter and rod, which may result in the prongs of the inserter becoming misshaped and broken. The rotating rod inserter was inspected and determined to not be in functional condition and was removed from distributable inventory.

 
Event Description

The complainant requested to return a serious of broken instruments for replacement. The complainant was unable to provide details regarding the incidents. There were no known patient complications associated with the malfunctions. The following mdrs are related to the receipt of this complaint. 3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.

 
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Brand NameXPRESS MINIMALLY INVASIVE PEDICLE 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 Key8457353
MDR Text Key140129331
Report Number3005031160-2019-00018
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
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 03/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2019
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? Device Returned To Manufacturer
Date Returned to Manufacturer03/06/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/15/2016
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: 03/27/2019 Patient Sequence Number: 1
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