MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PRESTIGE DISC; PROSTHESIS, INTERVERTEBRAL DISC

Model Number MSB_UNK_DISC_PRSTG

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

Patient Problems Apnea (1720); Erythema (1840); Extravasation (1842); Fatigue (1849); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Rash (2033); Visual Disturbances (2140); Post Traumatic Wound Infection (2447); Shaking/Tremors (2515); Swollen Lymph Nodes/Glands (4432); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

B3: date of event is unknown.D4: product identifiers unknown.E1: facility name is unknown.G4: product identifiers unknown.So 510k unknown.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.(annex g) component: prestige artificial disc.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 a (regulatory body, patient) via manufacturer representative regarding a patient who was implanted with medatronic prestige disc "5*60" at the 6/7 cervical level and the medtronic prestige disc "5*16" at 5/6 cervical level.It was reported that patient had a two level cervical disc replacement in 2021 and had trouble about one week after surgery.The incision opened back up and took weeks to heal.Patient started having weird rashes, welts, weakness, shaking, cramps.The symptoms just kept on increasing to include temporary paralysis of hands, arms, fingers, vision changes.Months later patient got sicker and had lost the ability to pick up my feet lower legs.Cardiovascular symptoms like high blood pressure, elevated d -dimer, elevated and troponin were reported.With no health problems in my cardiovascular system.Patient also developed polycerthmia vera, swollen hillar lymph node, bleeding in right lung, erythema of stomach lining, white spots on brain not in ms pattern, small blood vessel disease, a angiokeratoma, sleep apnea and excruciating pain.There have been over 20 visits.Patient was ill from the aluminum and nickel discs.These discs have caused metallosis.One of them has moved forward such that it was indenting the esophagus.Patient had aluminum in the system on paper since 2022, it was just at a lower level.Patient also suspect that the aluminum was leaking into my body much earlier.Event stated as life threatening and require intervention.There were no further complications that were reported.

• Brand Name: PRESTIGE DISC
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• 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: 18012242
• MDR Text Key: 326678366
• Report Number: 1030489-2023-00717
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_DISC_PRSTG
• Device Catalogue Number: MSB_UNK_DISC_PRSTG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention