MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 3 LEVEL 45MM FIXED PLATE; MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-522345
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
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
It was reported that a distributor received a bag labeled as a maxan 3-level plate, but it actually contained a maxan 1-level plate.There was no patient involvement.
Additional Manufacturer Narrative
Inspection the returned device was examined.Visual inspection revealed that a one-level plate was packaged in a sealed 3-level plate bag.Dhr review the initial manufacturing dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it initially left highridge medical¿s control.Potential root cause it was determined that the issue has been occurring during the loose inventory receipt and traveler initiation step, where product (part number, lot number) is incorrectly identified.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.
Event or Problem Description
It was reported that a distributor received a bag labeled as a maxan 3-level plate, but it actually contained a maxan 1-level plate.There was no patient involvement.

• Brand Name: 3 LEVEL 45MM FIXED PLATE
• Common Device Name: 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: teresa george ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035018506
• MDR Report Key: 16438870
• Report Number: 3012447612-2023-00053
• Device Sequence Number: 20643198
• Product Code: KWQ
• UDI-Device Identifier: 00880304960916
• UDI-Public: (01)00880304960916(10)J6537771
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133518
• 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): 07/26/2024

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: 14-522345
• Device Lot Number: J6537771
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/08/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 07/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic