MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 5.5 HIGH HEX COBALT CHROME ROD, 510MM; 5.5 POLARIS SPINAL SYSTEM

Catalog Number	14-500591
Medical Device Problem Codes	Missing Information (4053); Wrong Label (4073)
Health Effect - Clinical Code	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.Reference report 3012447612-2024-00382.
Event or Problem Description
A hospital reported that they received two packages labelled for cobalt chrome rods but actually contained titanium rods.Additionally, the regular device label was missing information including the description, manufacturing date, and ce marking.(only one label for the part number and another for the lot number).There was no patient involvement.This is report two of two for this event.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to improper repackaging practices.Dhr review: the dhr was unable to be located.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.
Event or Problem Description
A hospital reported that they received two packages labelled for cobalt chrome rods but actually contained titanium rods.Additionally, the regular device label was missing information including the description, manufacturing date, and ce marking.(only one label for the part number and another for the lot number).There was no patient involvement.This is report two of two for this event.

• Brand Name: 5.5 HIGH HEX COBALT CHROME ROD, 510MM
• Common Device Name: 5.5 POLARIS SPINAL 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: 20904607
• Report Number: 3012447612-2024-00383
• Device Sequence Number: 9156050
• Product Code: NKB
• UDI-Device Identifier: 00880304973701
• UDI-Public: (01)00880304973701(10)2479721
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091067
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 Catalogue Number: 14-500591
• Device Lot Number: 2479721
• Was Device Available for Evaluation?: No
• 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: 12/11/2024
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Ethnicity: Non Hispanic