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

Catalog Number	58-102203045
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to resolve on (b)(6) 2024 that a patient who underwent a three-level anterior cervical discectomy and fusion surgery about one year ago required a revision surgery.It could be seen on x-ray that a screw had backed out of the coda plate.The patient was brought to surgery on (b)(6) 2024 to revise the screw.Once the surgeon had dissected down to the plate, he saw that the locking mechanism of the plate had broken on one side and there was a loose piece of metal inside the screw head.The surgeon decided to remove the loose piece of metal and the screw that had backed out.He did not insert another screw or replace the plate as the contralateral side of the locking mechanism was still intact.

• 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 ; 9062269909
• MDR Report Key: 21186115
• Report Number: 1833824-2025-42465
• Device Sequence Number: 4300310
• Product Code: KWQ
• UDI-Device Identifier: 00840298701216
• UDI-Public: 00840298701216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/15/2025

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: 58-102203045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/17/2025
• 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