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

Catalog Number	58-102203045
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available, or does not apply, the section of the form is left blank.
Event or Problem Description
It was reported to resolve on (b)(6) 2024 that the caudal screws of a three-level coda plate were backing out.It was also said that the patien'ts spine was out of alignment following surgery.Due to the screw backout and the misalignment of the spine, a revision surgery was performed.

• 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: 20924539
• Report Number: 1833824-2024-42126
• Device Sequence Number: 12029096
• Product Code: KWQ
• UDI-Device Identifier: 00840298701216
• UDI-Public: (01)00840298701216
• 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
• 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): 12/10/2024

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: 58-102203045
• Device Lot Number: 461440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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