MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 1-LEVEL 20MM FIXED PLATE; MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-522120
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a client received a package labelled for a maxan 1-level 20mm fixed plate (14-5221120) that actually contained a maxan 2-level 20mm fix plate (14-522220).There was no patient involvement.
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.
Event or Problem Description
It was reported that a client received a package labelled for a maxan 1-level 20mm fixed plate (14-5221120) that actually contained a maxan 2-level 20mm fix plate (14-522220).There was no patient involvement.
Additional Manufacturer Narrative
H6 investigation type additional code: 4109.Corrections in d4: lot number and udi number, d9, g1, h3, and h4.Additional information in h6: component, investigation type, findings, and conclusions.Inspection the returned device matches the information in the complaint file and was examined.Visual inspection revealed the returned device is part number 14-522220 lot j3549823.A bag/label was not received.No signs of damage.A photo was provided, which shows a sealed package labeled as a 1 level plate (pn (b)(4), ln 166430) containing a 2 level plate.Dhr review the "loose inventory repack traveler" dhr indicated that the device was likely conforming when it left highridge medical¿s control.However, based on the inspection of the returned device, it is now known that the device was not conforming.Potential root cause the root cause of this issue is likely associated with the repackaging process and an internal capa.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: 1-LEVEL 20MM 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 19479700
• Report Number: 3012447612-2024-00114
• Device Sequence Number: 17889714
• Product Code: KWQ
• UDI-Device Identifier: 00880304961302
• UDI-Public: (01)00880304961302(10)166430
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 14-522120
• Device Lot Number: 166430
• 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: 06/06/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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