MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 4.0MM X 14MM VARIABLE SCREW; MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-521614
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
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 packaged maxan screw was labeled as 14-521614 but actually had a 14-521514 screw in the package.There was no patient involvement.
Additional Manufacturer Narrative
Corrections in g1 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed that the label is for a variable screw, but it contains a fixed screw.The entire screw is fully colored.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.Dhr review: the 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 left highridge medical¿s control.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.
Event or Problem Description
It was reported that a packaged maxan screw was labeled as 14-521614 but actually had a 14-521514 screw in the package.There was no patient involvement.

• Brand Name: 4.0MM X 14MM VARIABLE SCREW
• 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: 16484935
• Report Number: 3012447612-2023-00058
• Device Sequence Number: 14930579
• Product Code: KWQ
• UDI-Device Identifier: 00880304961890
• UDI-Public: (01)00880304961890(10)J30643
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K080646
• 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: 14-521614
• Device Lot Number: J30643
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 07/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• 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