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U.S. Department of Health and Human Services

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

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PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW Back to Search Results
Model Number UNKNOWN
Device Problems Break (1069); Difficult to Insert (1316)
Patient Problem Intraoperative Pain (2662)
Event Date 07/11/2016
Event Type  malfunction  
Manufacturer Narrative
The broken screw was not returned for evaluation. The surgical technique for this product line describes the proper use of spinal rod contouring. In this surgery the surgeon did not contour the rod, which may have led to the difficulty in locking the set screw. Requests were made for initial surgery and supporting surgical records but these have not been made available. No further information is available at this time. Device not returned for evaluation.
 
Event Description
On (b)(6) 2016 the patient was revised for a broken pedicle screw in a single level posterior spinal rod fusion construct. The surgeon took out the broken screw and added another level to the construct. During this process there were difficulties in locking a set screw onto the pedicle screw. This difficulty extended the surgery time.
 
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Brand NamePIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW
Type of DevicePEDICLE SCREW
Manufacturer (Section D)
PIONEER SURGICAL (D.B.A. RTI SURGICAL)
375 river park circle
marquette MI 49855
Manufacturer (Section G)
PIONEER SURGICAL (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 Key5890812
MDR Text Key52734642
Report Number1833824-2016-00030
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 other
Reporter Occupation
Type of Report Initial
Report Date 08/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/19/2016 Patient Sequence Number: 1
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