MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 12MM LAMINOPLASTY PLATE W/ HOOK; GALLERY LAMINOPLASTY FIXATION SYSTEM

Catalog Number	14-523232
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a bag labeled for a gallery 12mm plate with hook actually contained a gallery 10mm plate with hook.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.
Additional Manufacturer Narrative
Additional information in d4: udi number, h4, and h6: component, investigation type, findings, and conclusions.Inspection: the device was not returned and no photos were provided, so an evaluation is unable to be performed.The failure of device in package not matching what was on the label remains unrefuted.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to a packaging or inspection error.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 bag labeled for a gallery 12mm plate with hook actually contained a gallery 10mm plate with hook.There was no patient involvement.

• Brand Name: 12MM LAMINOPLASTY PLATE W/ HOOK
• Common Device Name: GALLERY LAMINOPLASTY FIXATION 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 19281651
• Report Number: 3012447612-2024-00087
• Device Sequence Number: 12346202
• Product Code: NQW
• UDI-Device Identifier: 00880304960237
• UDI-Public: (01)00880304960237(10)3136642
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100805
• 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): 06/02/2024

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: 14-523232
• Device Lot Number: 3136642
• Was Device Available for Evaluation?: No
• 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: 05/09/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2024
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic