MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. MEDIUM CROSS CONNECTOR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	94672
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
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 3012447612-2025-00339.
Event or Problem Description
A distributor reported that they received two polaris 5.5 cross connectors that differed from the packaging labels.The connectors inside the packages were not size m, as indicated, but size xs.This was discovered prior to surgical use and there was no patient impact.This is report two of two for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.A visual inspection revealed the package label states part number 94672 however, the packaged device is part number 94671.The complaint is confirmed for polaris 5.5 cross connector for the failure of incorrect part in package.This event fits within the scope of an existing internal capa.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 distributor reported that they received two polaris 5.5 cross connectors that differed from the packaging labels.The connectors inside the packages were not size m, as indicated, but size xs.This was discovered prior to surgical use and there was no patient impact.This is report two of two for this event.

• Brand Name: MEDIUM CROSS CONNECTOR
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW 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: 23479711
• Report Number: 3012447612-2025-00340
• Device Sequence Number: 10329626
• Product Code: NKB
• UDI-Device Identifier: 00888480476337
• UDI-Public: (01)00888480476337(10)2484731
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033312
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 94672
• Device Lot Number: 2484731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/05/2025
• Supplement Report FDA Received Date: 04/10/2026
• 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