MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 2-LEVEL 28MM FIXED PLATE; MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-522228
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
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 ring dislodged from a maxan plate while the screw was being implanted.Another plate was used to complete the case.There was a 15-minute delay without any impact to the patient.
Additional Manufacturer Narrative
Device evaluation.Visual inspection prior to sterilization revealed that one of the rings was disassembled from the device.The ring was subsequently lost in the autoclave.Potential cause root cause was unable to be determined.This event could possibly be attributed to improper interference between the ring and the screw during insertion.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Device use 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 ring dislodged from a maxan plate while the screw was being implanted.Another plate was used to complete the case.There was a 15-minute delay without any impact to the patient.

• Brand Name: 2-LEVEL 28MM 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15914758
• Report Number: 3012447612-2022-00277
• Device Sequence Number: 6535774
• Product Code: KWQ
• UDI-Device Identifier: 00880304961173
• UDI-Public: (01)00880304961173(10)J6916016
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K133518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: Health Professional
• Device Catalogue Number: 14-522228
• Device Lot Number: J6916016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2020
• 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 Age: 49 YR
• Patient Sex: Female