MAUDE Adverse Event Report: RTI SURGICAL RTI SURGICAL STREAMLINE MIS 7.5 MM X 45 MM PEDICLE SCREW; SPINAL PEDICLE SCREW

Model Number	05-PA-75-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record was reviewed and product was made to specifications.Dimensional inspection was done for the returned broken screw and all dimensions were found to be within specifications.The broken screw is currently under evaluation.
Event or Problem Description
Three weeks post-op the patient was experiencing pain after a posterior lumbar fusion surgery.A follow up visit with the surgeon determined that a pedicle screw had broke.The patient was revised.The broken screw was taken out and the patient is in stable condition and recovering.

• Brand Name: RTI SURGICAL STREAMLINE MIS 7.5 MM X 45 MM PEDICLE SCREW
• Common Device Name: SPINAL PEDICLE SCREW
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 7530149
• Report Number: 1833824-2018-00011
• Device Sequence Number: 11186646
• Product Code: NKB
• UDI-Device Identifier: 00846468052522
• UDI-Public: (01)00846468052522(10)226701
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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: Physician
• Device Model Number: 05-PA-75-45
• Device Catalogue Number: SAME
• Device Lot Number: 226701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/21/2018
• 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
• Patient Age: 70 YR
• Patient Weight: 82