MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 4.0MM X 14MM VARIABLE SCREW; C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-521614E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that two maxan screws at the bottom end of the construct fractured approximately 18 months post-operatively.A revision surgery is scheduled.This is report one of two for this event.
Event or Problem Description
It was reported that two maxan screws at the bottom end of the construct fractured approximately 18 months post-operatively.A revision surgery was initially scheduled, but was cancelled because the patient is not experiencing any symptoms.This is report one of two for this event.
Additional Manufacturer Narrative
H6: additional method code: 4109.Corrections in b1, b5, h1, h6: patient and impact codes.Additional information in d4: expiration date & udi number, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however x-rays were provided which show that the two screws at the bottom of the construct are fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3012447612-2023-00387.

• Brand Name: 4.0MM X 14MM VARIABLE SCREW
• Common Device Name: C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18301854
• Report Number: 3012447612-2023-00386
• Device Sequence Number: 6936800
• Product Code: KWQ
• UDI-Device Identifier: 00880304984936
• UDI-Public: (01)00880304984936(17)310331(10)J76720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080646
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 14-521614E
• Device Lot Number: J76720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic