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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
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
As of the date of this report, the device remains implanted in patient. A dhr review could not be conducted as the lot number is unknown. The surgeon intends to perform revision but the that revision surgery date is unknown at this time. This report will be updated should additional data, or the device become available at a later date.
 
Event Description
This incident was reported to rti surgical on (b)(6) 2020 via (b)(6) bfarm report number, 21763_20. The report states that following the index surgery that was performed on (b)(6) 2019, a streamline mis pedicle screw disassociated post-operatively. Revision surgery is planned, but has not yet taken place.
 
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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 Key11048563
MDR Text Key223797986
Report Number1833824-2020-00097
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 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received11/24/2020
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: 12/21/2020 Patient Sequence Number: 1
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