MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CENTERPIECE PLATE FIXATION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 8530810

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

B2: outcome attributed to adverse event- fractured vertebral arch.H3 - neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) via a manufacturer representative regarding screws and plates with spinal therapy.It was reported that an attempt was made to enlarge the vertebral arch during the trial, however, the vertebral arch was partially transected.There were no further complications reported regarding the event.Additional information received that patient had reported dissection of the vertebral arch.Pre-op diagnosis for the patient was cervical spondylosis raw myelopathy.Procedure involved in this event was cervical laminoplasty.There was no revision surgery planned/ occurred as a result of the event.Patient had fractured vertebral arch during use of trial at upper c4-c5.There was no failure of the trial itself and there were no defects in the reported products.Laminectomy was performed and the wound was closed.

• Brand Name: CENTERPIECE PLATE FIXATION
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18473591
• MDR Text Key: 332377809
• Report Number: 1030489-2024-00030
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885074540979
• UDI-Public: 00885074540979
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8530810
• Device Catalogue Number: 8530810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other