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

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.

• Brand Name: RTI SURGICAL STREAMLINE MIS 5.5MM X 40MM PEDICLE SCREW
• Type of Device: PEDICLE 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 Key: 7583238
• MDR Text Key: 110588994
• Report Number: 1833824-2018-00020
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468052294
• UDI-Public: (01)00846468052294(10)213188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• 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 Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05-PA-55-40
• Device Catalogue Number: N/A
• Device Lot Number: 213188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention