MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC. CODA ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	58-102250018
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.
Event or Problem Description
On (b)(6) 2024, dr.(b)(6) performed a c3-6 acdf using proti acis and a coda plate.It was reported to pioneer on (b)(6) 2024 that the patient was scheduled for a revision surgery to happen on (b)(6) 2024 to extend the construct down to c7.Preoperative x-rays for the extension surgery showed that the coda screws in the c6 body appeared to be broken and were backing out of the plate.A revision surgery then occurred.Patient outcome is unknown following revision surgery.

• Brand Name: CODA ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• 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: 375 river park circle; marquette, MI 49855
• MDR Report Key: 20694266
• Report Number: 1833824-2024-42210
• Device Sequence Number: 3757364
• Product Code: KWQ
• UDI-Device Identifier: 00840298702442
• UDI-Public: (01)00840298702442
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K230993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 11/12/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 58-102250018
• Device Lot Number: 9463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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