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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RTI SURGICAL RTI SURGICAL STREAMLINE TL SET SCREW STREAMLINE SET SCREW

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RTI SURGICAL RTI SURGICAL STREAMLINE TL SET SCREW STREAMLINE SET SCREW Back to Search Results
Model Number 01-SETSCREW
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2018
Event Type  malfunction  
Manufacturer Narrative
Device history review was completed and the implant met all specifications. Several attempts have been made to get the original surgical date with no success. The patient is recovering.
 
Event Description
It was discovered at a post-op appointment that the screw was backing out. The patient was not in pain. The surgeon revised the patient on (b)(6) 2018. Patient is recovering.
 
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Brand NameRTI SURGICAL STREAMLINE TL SET SCREW
Type of DeviceSTREAMLINE SET 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 Key7645105
MDR Text Key112559934
Report Number1833824-2018-00026
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00846468006143
UDI-Public(01)00846468006143(10)298476
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140696
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number01-SETSCREW
Device Catalogue NumberSAME
Device Lot Number298476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2017
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: 06/28/2018 Patient Sequence Number: 1
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