MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RST) PIONEER SURGICAL TECHNOLOGY; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 58-102250016

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

A three month post op xray was provided on (b)(6) 2023 of an image of a screw that backed out of a plate in a patient.Revision surgery is not scheduled at this time.

Manufacturer Narrative

Device was not returned to resolve surgical for inspection.Part and batch information remains unknown at this time.Multiple attempts were made to gather data from the rep.And no more information is available at this time.

• Brand Name: PIONEER SURGICAL TECHNOLOGY
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RST); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY (D.B.A. RST); 375 river park circle; marquette MI 49855
• Manufacturer Contact: katie moyle ; 375 river park circle; marquette, MI 49855 ; 9062255620
• MDR Report Key: 17845700
• MDR Text Key: 324617458
• Report Number: 1833824-2023-00200
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222493
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58-102250016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2023
• 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