MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ZEVO¿ ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD

Model Number	7713518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional via manufacturer representative regarding a screw used in anterior cervical discectomy and fusion therapy.It was reported that the screw head broke off from the shaft upon insertion.The shank of the screw remained in the vertebral body, unable to back out once the head of the screw sheared off from the shank during implantation.It was a normal approach to placing screws.Awl was used to create pilot hole for the screw.This was the fifth screw going in of eight total.The head of the screw sheared off from the shank when advancing the screw through the screw hole in the plate and into the vertebral body.No patient symptoms were reported.No further complications were reported/anticipated.
Additional Manufacturer Narrative
H3: product analysis of part # 7713518 ; lot # unknown visual and optical inspection confirmed the screw head has broken from the threaded shaft.This type of damage is consistent with torsional overload.This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ZEVO¿ ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21236283
• Report Number: 1030489-2025-00336
• Device Sequence Number: 8055951
• Product Code: KWQ
• UDI-Device Identifier: 00643169329300
• UDI-Public: 00643169329300
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141632
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2025

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 Model Number: 7713518
• Device Catalogue Number: 7713518
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 01/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 146 KG