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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL (D.B.A. RTI SURGICAL) STREAMLINE TL PEDICLE SCREW SYSTEM

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PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL (D.B.A. RTI SURGICAL) STREAMLINE TL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 01-RS-C-75-35
Device Problem Disassembly (1168)
Patient Problem Intraoperative Pain (2662)
Event Date 12/21/2017
Event Type  Injury  
Manufacturer Narrative
Since the pedicle screw was not returned there was no evaluation of the actual device performed. Since the lot number and part number were not made available by the user of this device there was no dhr review. No further information was available for this occurrence.
 
Event Description
It was reported to pioneer surgical that a patient needed to be revised due to a pedicle screw that had disassembled sometime after the initial surgery in (b)(6) 2016. The patient was revised on (b)(6) 2017.
 
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Brand NamePIONEER SURGICAL (D.B.A. RTI SURGICAL) STREAMLINE TL PEDICLE SCREW SYSTEM
Type of DevicePEDICLE SCREW
Manufacturer (Section D)
PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
375 river park circle
marquette MI 49855
Manufacturer (Section G)
PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
375 river park circle
marquette MI 49855
Manufacturer Contact
dan nelson
375 river park circle
marquette, MI 49855
9062264489
MDR Report Key7205423
MDR Text Key97731535
Report Number1833824-2018-00001
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140696
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number01-RS-C-75-35
Device Catalogue NumberSAME
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/19/2018 Patient Sequence Number: 1
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