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

Model Number 05-PA-65-45

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/11/2020

Event Type  malfunction  

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 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
• Type of Device: PEDICLE SCREW,
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 10977770
• MDR Text Key: 220501467
• Report Number: 1833824-2020-00096
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468052546
• UDI-Public: (01)00846468052546(10)375161
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2020
• 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): Other