MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 4.0MM X 12MM FIXED SCREW; C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	14-521512E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Subluxation (4525)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
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.Reference reports 3004788213-2022-00022 through 3004788213-2022-00025 and 3012447612-2022-00072 through 3012447612-2022-00076.
Event or Problem Description
It was reported that a patient underwent a second operation to perform a laminectomy.The initial operation was performed to fix a c4,c5, and c6 hernia and c5 spondylolisthesis using anterior fixation with roi-c and maxan.Postoperatively, the spondylolisthesis at c5 returned and the c6 vertebral body broke at the point where the roi-c plate and maxan screw tip meet in the vertebral body.A laminectomy was performed and the implants remain implanted.The patient did not have any pain or side effects of the breakage or spondylolisthesis.This is report six of nine for this event.
Event or Problem Description
It was reported that a patient underwent a second operation to perform a laminectomy.The initial operation was performed to fix a c4,c5, and c6 hernia and c5 spondylolisthesis using anterior fixation with roi-c and maxan.Postoperatively, the spondylolisthesis at c5 returned and the c6 vertebral body broke at the point where the roi-c plate and maxan screw tip meet in the vertebral body.A laminectomy was performed and the implants remain implanted.The patient did not have any pain or side effects of the breakage or spondylolisthesis.This is report six of nine for this event.
Additional Manufacturer Narrative
Device evaluation: product was not returned as it remains implanted, however x-rays were provided.The fractured bone is seen in the x-rays.Device evaluation is unable to be performed to determine further relation between the devices and the event.Potential cause: root cause was unable to be determined.This event could possibly be attributed to improper evaluation of bone structure, improper procedural strategy for this incident, or unknown patient or traumatic factors.Dhr review and related actions per dhr review, the parts were likely conforming when they left zimvie control.Device usage these devices are 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: 4.0MM X 12MM FIXED SCREW
• Common Device Name: C-TEK 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: 13932406
• Report Number: 3012447612-2022-00073
• Device Sequence Number: 3889115
• Product Code: KWQ
• UDI-Device Identifier: 00880304985353
• UDI-Public: (01)00880304985353(17)290915(10)J08116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 14-521512E
• Device Lot Number: J08116
• Was Device Available for Evaluation?: No
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male