MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC CODA¿ ANTERIOR CERVICAL PLATE SYSTEM; 1 LEVEL PLATE

Model Number	58-102201012
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From the complainant: it was reported on an unknown date, that the surgeon reached out stating "the patient they used coda on came back today for 2 month post-op, one of her screws was backing out." he was almost positive they cam locked.And he remember seeing the cam swivel over to have both wings covering the screws on both levels" "if it backs out anymore, he may bring her back just to revise.May consider exchanging the plate itself for skyline, but he will let you know." additional information was received on 03/18/2026 that the surgeon and patient opted for a revision to be completed on (b)(6) 2026.The impacted device will be explanted and revised with a different product.
Additional Manufacturer Narrative
The event was evaluated and investigated with the information provided.A device evaluation was unable to be performed as a revision surgery is scheduled for (b)(6) 2026, where the sales rep indicated the device may be accessible for testing after the revision.No lot information has been provided to review the dhr for lot-related nonconformities.Further investigation activities will be performed if the device, or additional information, is provided.

• Brand Name: CODA¿ ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: 1 LEVEL PLATE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY, INC; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY, INC; 375 river park circle; marquette MI 49855
• Manufacturer Contact: timothy kolesar ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 24638829
• Report Number: 1833824-2026-00004
• Device Sequence Number: 10207657
• Product Code: KWQ
• UDI-Device Identifier: 00840298700998
• UDI-Public: 00840298700998
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K222493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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
• Operator of Device: Health Professional
• Device Model Number: 58-102201012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• 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: Required Intervention
• Patient Sex: Unknown