MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number 6971660C

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Neuropathy (1983); Neck Pain (2433); Neck Stiffness (2434)

Event Type  Injury  

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent extrapahryngeal anterolateral procedure at c4-c5, c5-c.Post- operatively approximately 83 months, the patient suffered from neck pain and stiffness.The investigator impression was: cervical stenosis, cervicalgia, cervical radiculitis.Pain management placed a spinal cord stimulator.Approximately 89 months postoperatively, the spinal cord stimulator was to be removed by pain management-not beneficial to patient.Approximately 105 months postoperatively, c-spine x-rays revealed no change.Approximately 123 months postoperatively, c-spine x-rays revealed some lucency, more around c5-c6 than at c4-c5.The implants were loose within disc space; solid fusion at c3-c4.Hospitalization had not been required.The outcome of this event is considered pending by the site.

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7288149
• MDR Text Key: 100644701
• Report Number: 1030489-2018-00256
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2010
• Device Catalogue Number: 6971660C
• Device Lot Number: W05M3370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• 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): Other
• Patient Age: 48 YR
• Patient Weight: 69