MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 4.5MM X 16MM VARIABLE SCREW; C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-521646E
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
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.Reference reports 3012447612-2022-00106 through 3012447612-2022-00109.
Event or Problem Description
It was reported that three screws could not be locked into a 4-level maxan plate.The three screws had to be replaced to complete the case.There was a 15-minute delay and no impact to the patient.This is report three of four for this event.
Additional Manufacturer Narrative
Corrections in d1 and d4: udi number.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation product was not returned and photos were not provided, so device evaluation could not be completed.Potential cause root cause was unable to be determined.This event could possibly be attributed to cross threading or inserting on an off-axis angle.Dhr review per dhr review, the parts were likely conforming when they left zimvie control.Device use these devices are 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.
Event or Problem Description
It was reported that three screws could not be locked into a 4-level maxan plate.The three screws had to be replaced to complete the case.There was a 15-minute delay and no impact to the patient.This is report three of four for this event.

• Brand Name: 4.5MM X 16MM 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 14197422
• Report Number: 3012447612-2022-00108
• Device Sequence Number: 4556782
• Product Code: KWQ
• UDI-Device Identifier: 00880304984714
• UDI-Public: (01)00880304984714(17)240930(10)J02238
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 14-521646E
• Device Lot Number: J02238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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
• Patient Sex: Unknown