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

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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, post-op, patient underwent explant surgery.The implant was found loose while removal surgery.No further information was provided.

Manufacturer Narrative

Additional information: x-ray image review: post-op x-ray for multiple cervical surgery fused levels are possibly c6-7, c5-6 with an artificial disc at c4-5.The artificial disc is translated anteriorly.I suspect placement of an artificial disc appear a multi-level fusion in anterior side of the indication for use and motion at this functional segment contributed to implant failure.If information is provided in the future, a supplemental report will be issued.

• 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: 7359025
• MDR Text Key: 103089715
• Report Number: 1030489-2018-00425
• 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,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 04/16/2018
• 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