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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 TECHNOLOGY STREAMLINE TL SYSTEM, SET SCREW SPINAL ROD SET SCREW

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PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY STREAMLINE TL SYSTEM, SET SCREW SPINAL ROD SET SCREW Back to Search Results
Model Number 01-SETSCREW
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Intraoperative Pain (2662)
Event Type  Injury  
Manufacturer Narrative
A full investigation could not be performed since the device was not returned for evaluation and after repeated attempts no information could be gathered about the patient, surgeries or the hospital. Device not returned.
 
Event Description
It was discovered in the country of austria that a posterior spinal rod set screw came loose approximately 6 weeks post operatively. The patient was revised and the set screw was removed and replaced. No other information is available at this time.
 
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Brand NamePIONEER SURGICAL TECHNOLOGY STREAMLINE TL SYSTEM, SET SCREW
Type of DeviceSPINAL ROD SET 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 Key6660455
MDR Text Key78177304
Report Number1833824-2017-00018
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAU
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 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number01-SETSCREW
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?
Event Location No Information
Date Manufacturer Received05/23/2017
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/22/2017 Patient Sequence Number: 1
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