MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE MIS SYSTEM; PEDICLE SCREW

Model Number	05-PA-75-40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted screw was not returned to rti surgical for evaluation.A dhr review was conducted and confirmed that this device met manufacturing specification prior to shipping from rti surgical.On april 15, 2020 rti surgical mqt was able to confirm that hardware did break within the patient.1 of 2 mdrs reported for this occurrence.The 2nd mdr is on report number 1833824-2020-00022.
Event or Problem Description
A revision surgery took place on (b)(6) 2019 to remove broken hardware.Index surgery was performed on (b)(6) 2017.The patient reported pain in (b)(6) of 2018 where "there was evidence of l5-s1 intervertebral hardware subsidence projecting into the interior l5 vertebral body.".

• Brand Name: PIONEER SURGICAL STREAMLINE MIS SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• MDR Report Key: 10058384
• Report Number: 1833824-2020-00021
• Device Sequence Number: 16847327
• Product Code: NKB
• UDI-Device Identifier: 00846468052515
• UDI-Public: (01)00846468052515(10)262465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 05-PA-75-40
• Device Catalogue Number: SAME
• Device Lot Number: 262465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/14/2020
• 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: Congenital Anomaly; Hospitalization
• Patient Age: 35 YR