MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. DIA. 5.5 STRAIGHT RODS, TI ALLOY 450MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	07.02013.002
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 receiving two orders with mislabeled vitality ti 450mm rods.The first of these was instead a 25mm ti rod and the second was a cobalt-chrome 450mm rod.There was no patient involvement.This is report one of two for this event.
Event or Problem Description
A distributor reported receiving two orders with mislabeled vitality ti 450mm rods.The first of these was instead a 25mm ti rod and the second was a cobalt-chrome 450mm rod.There was no patient involvement.This is report one of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the packaged device is labeled as part number 07.02013.002 lot p140994 (5.5 x 450mm ti alloy rod), however the device in the package is laser marked part number 07.02016.002 lot p140994 (5.5 x 450mm cocr rod).Root cause: the capa found the causes are attributed to improper repackaging practices related to product identification.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 label did not match the part number that is laser marked on the product in the package.An internal capa has been previously opened to address this issue.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 3012447612-2025-00039.

• Brand Name: DIA. 5.5 STRAIGHT RODS, TI ALLOY 450MM
• 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: 21333932
• Report Number: 3012447612-2025-00038
• Device Sequence Number: 3758442
• Product Code: NKB
• UDI-Device Identifier: 00889024003507
• UDI-Public: (01)00889024003507(10)P140994
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150896
• 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): 06/24/2025

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: Other
• Device Catalogue Number: 07.02013.002
• Device Lot Number: P140994
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2025
• 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: 02/07/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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: Unknown
• Patient Ethnicity: Non Hispanic