MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 4.0MM X 18MM VARIABLE SCREW; C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-521618E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
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 fractured 4 years post-op at level c6 of a 2 level plate at c4-c6.A revision surgery was performed with the threaded part of both screws being retained in the patient; the full construct was replaced to c6/c7/t1.This is report one of two for this event.
Event or Problem Description
It was reported that two maxan screws fractured 4 years post-op at level c6 of a 2 level plate at c4-c6.A revision surgery was performed with the threaded part of both screws being retained in the patient; the full construct was replaced to c6/c7/t1.This is report one of two for this event.
Additional Manufacturer Narrative
H6: additional method code: 4110.Corrections in d9, g1, and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the screw shank has 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 (b)(6) 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 3012447612-2023-00350.

• Brand Name: 4.0MM X 18MM 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: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 18061858
• Report Number: 3012447612-2023-00349
• Device Sequence Number: 12718740
• Product Code: KWQ
• UDI-Device Identifier: 00880304984899
• UDI-Public: (01)00880304984899(17)260216(10)J25091
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: Health Professional
• Device Expiration Date: 02/15/2026
• Device Catalogue Number: 14-521618E
• Device Lot Number: J25091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 11/02/2023
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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; Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic