MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

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

Patient Problems Anemia (1706); Fatigue (1849); Headache (1880); Neuropathy (1983); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Implant date: month and year valid.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.Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent surgery using cervical implant.Post-op, auto immune issues have developed synovitis in hands in feet, abnormal platelet functions, neuropathy in arms, headaches, fatigue, rash-but not at neck where implant is.Anemia- unexplained.There¿s a consideration of another surgery.

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7538282
• MDR Text Key: 109055430
• Report Number: 1030489-2018-00733
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention