MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. OPTIO-C, PLATE, 7MM; OPTIO-C ANTERIOR CERVICAL SYSTEM

Catalog Number	07.01873.007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the surgeon implanted the optio-c device by impacting it in order to get the implant seated, and as the surgeon was in the process of final tightening, the locking plate broke.The surgeon removed the implant and used a different one to complete the case.There was a 10-minute delay without any impact to the patient.
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
Corrections in d9 and h3.Additional information in d4: expiration date & udi number, h4, and 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 device was fractured and disassembled.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during use.This event could possibly be attributed to unknown patient or surgical factors.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 after the surgeon implanted the optio-c device by impacting it in order to get the implant seated, and as the surgeon was in the process of final tightening, the locking plate broke.The surgeon removed the implant and used a different one to complete the case.There was a 10-minute delay without any impact to the patient.

• Brand Name: OPTIO-C, PLATE, 7MM
• Common Device Name: OPTIO-C ANTERIOR CERVICAL 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: 17637465
• Report Number: 3012447612-2023-00245
• Device Sequence Number: 6425884
• Product Code: KWQ
• UDI-Device Identifier: 00889024329607
• UDI-Public: (01)00889024329607(17)270515(10)10266
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141500
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: Health Professional
• Device Catalogue Number: 07.01873.007
• Device Lot Number: 10266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 08/28/2023
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 07.01849.007
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic