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U.S. Department of Health and Human Services

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

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PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) STREAMLINE MIS, PEDICLE SCREW SPINAL SCREW Back to Search Results
Model Number 05-PA-75-50
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Intraoperative Pain (2662)
Event Type  Injury  
Manufacturer Narrative
The dhr was reviewed for this device and it was recorded as being manufactured to specifications. After a review of the immediate post operative films and the films at the time of the occurrence by rti surgical's medical advisor as well as a review of the returned devices, the most likely cause of this occurrence was the placement of the screw during the initial surgery allowed for the dissassociation of the screw yoke potion. If further information becomes available, pioneer surgical will update this report. It is unknown the patient's information beyond the sex.
 
Event Description
(b)(6) reported incident - approximately 6 weeks post-op, the patient reported pain due to a 2 level surgery from l4 to s1 with a tlif approach with cage on the left side from l5/s1. It was discovered through x-ray that head of the screw at s1 on the right side popped off. Revision surgery was conducted on an unknown date, and type of reconstruction is undetermined as of reporting date.
 
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Brand NameSTREAMLINE MIS, PEDICLE SCREW
Type of DeviceSPINAL SCREW
Manufacturer (Section D)
PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
375 river park circle
marquette, mi
Manufacturer (Section G)
PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
375 river park circle
marquette, mi
Manufacturer Contact
daniel nelson
375 river park circle
marquette, mi 
2264489
MDR Report Key9943378
MDR Text Key191568820
Report Number1833824-2020-00020
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00846468052539
UDI-Public(01)00846468052539(10)342472
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 foreign,other
Reporter Occupation
Type of Report Initial
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number05-PA-75-50
Device Catalogue NumberSAME
Device Lot Number342472
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2019
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: 04/09/2020 Patient Sequence Number: 1
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