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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RTI SUGICAL RTI SURGICAL STREAMLINE MIS 5.5MM X 40MM PEDICLE SCREW

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RTI SUGICAL RTI SURGICAL STREAMLINE MIS 5.5MM X 40MM PEDICLE SCREW Back to Search Results
Model Number 05-PA-55-40
Device Problem Disassembly (1168)
Patient Problem Intraoperative Pain (2662)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
The tulip of the reported screw was returned to rti surgical, however, the screw itself was not. The tulip passed dimensional inspections. Visual inspections determined that the core tabs displayed no irregular markings that would be consistent with misuse. A failure mode could not be determined with results from inspections. A dhr review was conducted and has confirmed that this device met manufacturing specifications prior to shipping.
 
Event Description
It was reported to rti surgical that a 5. 5mm x 40mm streamline mis pedicle screw disassociated during a surgery on (b)(6) 2018. It was confirmed that there was no patient effect. The screw was removed and replaced with another screw. There was a surgical delay of 60 minutes.
 
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Brand NameRTI SURGICAL STREAMLINE MIS 5.5MM X 40MM PEDICLE SCREW
Type of DevicePEDICLE SCREW
Manufacturer (Section D)
RTI SUGICAL
375 river park circle
marquette MI 49855
Manufacturer (Section G)
RTI SUGICAL
375 river park circle
marquette MI 49855
Manufacturer Contact
daniel nelson
375 river park circle
marquette, MI 49855
9062264489
MDR Report Key7583238
MDR Text Key110588994
Report Number1833824-2018-00020
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00846468052294
UDI-Public(01)00846468052294(10)213188
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,other
Reporter Occupation
Type of Report Initial
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number05-PA-55-40
Device Catalogue NumberN/A
Device Lot Number213188
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2015
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: 06/08/2018 Patient Sequence Number: 1
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