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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 STREAMLINE MIS SYSTEM PEDICLE SCREW

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PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE MIS SYSTEM PEDICLE SCREW Back to Search Results
Model Number 05-PA-65-50
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Date 10/23/2020
Event Type  Injury  
Manufacturer Narrative
A dhr review was conducted and confirmed that the device met manufacturing specification prior to shipping from rti surgical. The screw was not returned to rti surgical for evaluation. This report will be updated should additional information become available or should the screw be returned to rti surgical at a later date.
 
Event Description
It was reported to rti surgical on (b)(6) 2020 that a streamline mis pedicle screw disassociated post-operatively. Index surgery was performed on (b)(6) 2016. Revision surgery to replace the screw was performed on (b)(6) 2020. The screw is not available for evaluation.
 
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Brand NamePIONEER SURGICAL STREAMLINE MIS SYSTEM
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
daniel nelson
375 river park circle
marquette, MI 49855
MDR Report Key10977758
MDR Text Key220497475
Report Number1833824-2020-00094
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K130286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number05-PA-65-50
Device Catalogue NumberSAME
Device Lot Number234191
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/02/2016
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: 12/09/2020 Patient Sequence Number: 1
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