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

Model Number	05-PA-55-40
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): RTI SUGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 7583238
• Report Number: 1833824-2018-00020
• Device Sequence Number: 2011952
• Product Code: NKB
• UDI-Device Identifier: 00846468052294
• UDI-Public: (01)00846468052294(10)213188
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention