MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OPTIO-C,PEEK IB,12X14X8MM; OPTIO-C ANTERIOR CERVICAL SYSTEM

Catalog Number	07.01858.008
Medical Device Problem Codes	Fracture (1260); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implanting of an optio-c cage, the plate translated too far and broke the implant.A new implant was used to complete the case.There was no impact on the patient.
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.
Additional Manufacturer Narrative
Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed no signs of damage.Root cause: a definitive root cause cannot be determined since the returned device was found to function as expected.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 during implanting of an optio-c cage, the plate translated too far and broke the implant.A new implant was used to complete the case.There was no impact on the patient.

• Brand Name: OPTIO-C,PEEK IB,12X14X8MM
• 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 17058782
• Report Number: 3012447612-2023-00179
• Device Sequence Number: 20966576
• Product Code: OVE
• UDI-Device Identifier: 00889024329409
• UDI-Public: (01)00889024329409(17)240515(10)10139
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K132894
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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: Other
• Device Expiration Date: 05/14/2024
• Device Catalogue Number: 07.01858.008
• Device Lot Number: 10139
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/18/2023
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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