MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOOGIES 5.5 X 45MM STREAMLINE MIS SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 01-PA-55-45

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

Device not inspected due to remaining in the patient.No batch information was provided, so the manufacturing records could not be investigated.Repeated inquiries to gather more information about this case have not resulted in any additional information beyond what is listed in this report at this time.

Event Description

During a normal patient follow-ups, the surgeon noticed on x-ray that one of the mis set screws had backed out post-op from the original implantation date of (b)(6) 2022.The distributor was sent new torque handles and final drivers on 4/2/22, but they were unfortunately not used for this original case.The distributor is checking to see if they still have the original torque handle and final driver that would have been used in this case so that we can test.

• Brand Name: PIONEER SURGICAL TECHNOOGIES 5.5 X 45MM STREAMLINE MIS SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer Contact: cassy baij ; 357 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 14593435
• MDR Text Key: 301848459
• Report Number: 1833824-2022-00052
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192396
• 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: 06/02/2022

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
• Device Operator: Health Professional
• Device Model Number: 01-PA-55-45
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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