MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OPTIO-C, PLATE, 6MM; OPTIO-C ANTERIOR CERVICAL SYSTEM

Catalog Number	07.01873.006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
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.Reference reports 3012447612-2023-00019 through 3012447612-2023-00020.
Event or Problem Description
It was reported that two optio-c plates and a peek implant were broken upon mallet impact and had to be replaced to complete the surgery.There was no reported patient impact, but a minimal delay to replace the plates and implant occurred.This is report three of three for this event.
Event or Problem Description
It was reported that two optio-c plates and a peek implant were broken upon mallet impact and had to be replaced to complete the surgery.There was no reported patient impact, but a minimal delay to replace the plates and implant occurred.This is report three of three for this event.
Additional Manufacturer Narrative
Corrections in d4: udi number and h3.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information listed in the complaint file.Visual inspection of the device reveals that the light blue piece that sits atop the returned plate is bent; it does not sit to align properly with the rest of the part.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis impaction of the mallet.Dhr review: per dhr review, the part was likely conforming when it left zimvie 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.

• Brand Name: OPTIO-C, PLATE, 6MM
• 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16296620
• Report Number: 3012447612-2023-00021
• Device Sequence Number: 7492922
• Product Code: KWQ
• UDI-Device Identifier: 00889024329591
• UDI-Public: (01)00889024329591(17)270521(10)10281
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141500
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: 07.01873.006
• Device Lot Number: 10281
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/19/2023
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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