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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) RTI SURGICAL STREAMLINE MIS 06.5MM X 40MM DL MIS PEDICLE SCREW ASSY

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PIONEER SURGICAL (D.B.A. RTI SURGICAL) RTI SURGICAL STREAMLINE MIS 06.5MM X 40MM DL MIS PEDICLE SCREW ASSY Back to Search Results
Model Number 05-PA-65-40
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Intraoperative Pain (2662)
Event Date 08/28/2018
Event Type  malfunction  
Manufacturer Narrative
The device was returned to rti surgical and the components that were able to be inspected were within specifications. A dhr review was completed and the device was manufactured to rti specifications.
 
Event Description
Rti attempted to submit this initial report to the fda on (b)(6) 2018. It has recently come to our attention that this report did not go through the electronic submission completely and does not show up on the maude database. For this reason, rti surgical is resubmitting this initial report. The initial complaint "it was reported by a rep that a screw had disassociated post-operatively and as a result a revision surgery was done. ".
 
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Brand NameRTI SURGICAL STREAMLINE MIS 06.5MM X 40MM DL MIS PEDICLE SCREW ASSY
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
9062264489
MDR Report Key9415603
MDR Text Key219787774
Report Number1833824-2018-00032
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00846468052362
UDI-Public(01)00846468052362(10)289680
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
130286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number05-PA-65-40
Device Catalogue NumberN/A
Device Lot Number289680
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2017
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: 12/05/2019 Patient Sequence Number: 1
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