MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

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

Patient Problems Headache (1880); Loss of Range of Motion (2032); Tingling (2171); Disability (2371); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

Initial reporter was not provided in the medwatch.The reporter occupation as provided in the medwatch was "other".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.

Event Description

It was reported via medwatch that on (b)(6) 2017, the patient underwent one-level cervical spine surgery.Post-op, the patient alleged to have debilitating cervical pain that was not present prior to surgery.The patient also alleged disability/permanent damage.Reportedly, "symptoms began right after the surgery and have not improved.Patient has completed conservative treatments to reduce or take pain away and none have worked.These include prescription pain medication, muscle relaxers, physical therapy, therapeutic massage and injections.Centered cervical neck pain is constant and daily.Patient cannot move head without severe pain centered on cervical spine.Patient cannot lay back or find any comfortable sleeping position.Pain feels skeletal, mechanical and severe in the cervical neck/spine region.Patient cannot lean forward or bend back without great pain.Cervical spine also locks up with motion and activity.Additionally, skull base has also resulted after surgery.Headache/head pain is constant and greatly reduce quality of life.Surgery was entered into for localized pain on left neck only.Patient had no loss of arm or hand function.Patient had no numbness, tingling in hands or arms, was not dropping things, was not falling and was driving a car with no issues prior to surgery.After surgery, daily activities are extremely difficult to complete.".

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7041372
• MDR Text Key: 92353229
• Report Number: 1030489-2017-02359
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P090029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• 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: 10/26/2017
• 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): Other; Disability