MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 4.5MM X 18MM VARIABLE SCREW; C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-521648
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
A distributor reported that they received three packages labeled as maxan variable screws, but actually containing fixed screws.This is report one of three for this event.
Event or Problem Description
A distributor reported that they received three packages labeled as maxan variable screws, but actually containing fixed screws.This is report one of three for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be removed.Corrections in g1 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the returned device was examined.Visual inspection revealed the package states 4.5mm x 18mm variable screw, however the screw inside the package is a fixed screw.Dhr review: the dhr was reviewed.It was initially recorded that there are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.It was later confirmed that the part number on the package did not match the part model in the package.A capa has been previously opened to address this issue.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to improper repackaging practices.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• Brand Name: 4.5MM 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: 19690795
• Report Number: 3012447612-2024-00144
• Device Sequence Number: 8122423
• Product Code: KWQ
• UDI-Device Identifier: 00880304961548
• UDI-Public: (01)00880304961548(10)949170
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080646
• Exemption Number: 5645646
• 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,Followup
• Report Date (Section B): 12/05/2024

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: Other
• Device Catalogue Number: 14-521648
• Device Lot Number: 949170
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2024
• 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: 07/08/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2024
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic