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

Model Number	05-PA-65-45
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to rti surgical missing the pedicle screw portion.Visual inspections found the device to be free from damage and the core tabs exhibit normal wear.A dhr review was conducted and confirms this device met manufacturing specifications prior to shipping from rti surgical.
Event or Problem Description
It was reported to rti surgical on (b)(6) 2020 that during a surgery, the threads of the screw broke off in the patient and could not be retrieved.Due to the broken threads, the surgeon skipped that level in surgery.

• 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 49855
• MDR Report Key: 10977770
• Report Number: 1833824-2020-00096
• Device Sequence Number: 4168969
• Product Code: NKB
• UDI-Device Identifier: 00846468052546
• UDI-Public: (01)00846468052546(10)375161
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 05-PA-65-45
• Device Catalogue Number: SAME
• Device Lot Number: 375161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/09/2020
• 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: Other