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

Catalog Number 6972460

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

Patient Problems Inadequate Pain Relief (2388); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

Patient demographics: height- 5'9"; race- caucasian.Pre-op diagnosis for initial surgery: spondylosis with foraminal stenosis (arm and neck pain) initial surgery: index surgery level implanted: c6/c7 reason for revision surgery: dislocation of periprosthetic tissue at c6/c7 revision surgery: acdf (anterior cervical discectomy and fusion) at c6/c7 it was reported that on an unknown date, post-op, patient symptoms of neck and arm pain did not resolve following the index surgery.Hence, a revision surgery was performed to revise the implant with acdf.

Manufacturer Narrative

Additional info.

Event Description

It was reported that, based on lateral intra-operative fluoroscopy, the disc appeared to be upside down with ball component placed inferior.

Manufacturer Narrative

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 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: 6546886
• MDR Text Key: 74473727
• Report Number: 1030489-2017-01112
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00613994493705
• UDI-Public: 00613994493705
• 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,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Catalogue Number: 6972460
• Device Lot Number: 0367858W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2015
• 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; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 69