MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY NS VARIABLE SELF DRILLING 3.5X14; CODA

Model Number	58-102250014
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Dps rep, (b)(6) , states "it was reported that surgeon saw a patient in clinic for 3 month follow up from a c4-7 acdf and noticed one of the c6 screws backing out of the plate.Dr was going to follow the patient and watch the implant, but is not planning on revising at this point as the patient is not symptomatic.The original case date was on (b)(6) 2024.There were no patient outcome.".
Additional Manufacturer Narrative
Device was not returned to resolve surgical for inspection.Batch information remains unknown at this time.Multiple attempts were made to gather data from the rep as well as the hospital that had information on the patient.

• Brand Name: PIONEER SURGICAL TECHNOLOGY NS VARIABLE SELF DRILLING 3.5X14
• Common Device Name: CODA
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer Contact: gina calcaterra ; 375 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 19018878
• Report Number: 1833824-2024-00586
• Device Sequence Number: 14423250
• Product Code: KWQ
• UDI-Device Identifier: 00840298702404
• UDI-Public: 00840298702404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/02/2024

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: 58-102250014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown