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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RTI SURGICAL RTI SURGICAL STREAMLINE MIS PEDICLE SCREW PEDICLE SCREW SYSTEM

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RTI SURGICAL RTI SURGICAL STREAMLINE MIS PEDICLE SCREW PEDICLE SCREW SYSTEM Back to Search Results
Model Number 05-PA-65-45
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
As of the date of this report the screw is still implanted in the patient, therefore a complete inspection could not be completed. The patient is recovering and the surgeon has no plans on a revision.
 
Event Description
The patient had surgery (b)(6) 2018. Approximately a month later it was identified that the screw disassociated. The patient is doing well and no revision is planned.
 
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Brand NameRTI SURGICAL STREAMLINE MIS PEDICLE SCREW
Type of DevicePEDICLE SCREW SYSTEM
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 Key7638783
MDR Text Key112851475
Report Number1833824-2018-00025
Device Sequence Number1
Product Code NKB
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 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number05-PA-65-45
Device Catalogue NumberSAME
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/30/2018
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

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