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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RTI SURGICAL RTI SURGICAL STREAMLINE MIS 7.5 MM X 45 MM PEDICLE SCREW SPINAL PEDICLE SCREW

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RTI SURGICAL RTI SURGICAL STREAMLINE MIS 7.5 MM X 45 MM PEDICLE SCREW SPINAL PEDICLE SCREW Back to Search Results
Model Number 05-PA-75-45
Device Problem Break (1069)
Patient Problem Intraoperative Pain (2662)
Event Date 04/23/2018
Event Type  Injury  
Manufacturer Narrative
Device history record was reviewed and product was made to specifications. Dimensional inspection was done for the returned broken screw and all dimensions were found to be within specifications. The broken screw is currently under evaluation.
 
Event Description
Three weeks post-op the patient was experiencing pain after a posterior lumbar fusion surgery. A follow up visit with the surgeon determined that a pedicle screw had broke. The patient was revised. The broken screw was taken out and the patient is in stable condition and recovering.
 
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Brand NameRTI SURGICAL STREAMLINE MIS 7.5 MM X 45 MM PEDICLE SCREW
Type of DeviceSPINAL PEDICLE SCREW
Manufacturer (Section D)
RTI SURGICAL
375 river park circle
marquette MI 49855
Manufacturer (Section G)
RTI SURGICAL
375 river park circle
marquette MI 49855
Manufacturer Contact
daniel nelson
375 river park circle
marquette, MI 49855
9062264489
MDR Report Key7530149
MDR Text Key108781752
Report Number1833824-2018-00011
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00846468052522
UDI-Public(01)00846468052522(10)226701
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number05-PA-75-45
Device Catalogue NumberSAME
Device Lot Number226701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2015
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: 05/21/2018 Patient Sequence Number: 1
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