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

Catalog Number	6972450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r reported event.
Event or Problem Description
The patient underwent arthroplasty at c5/c6 due to cervical herniated disc.Reportedly, post-op, the patient suffered with degenerative disc disease due to failed implant and underwent revision surgery for removal.The implant was removed with a ¼ osteotome and a clamp.No patient complications were reported after the revision surgery.
Additional Manufacturer Narrative
Additional information: image review x-ray image review: "post-op x-rays for c5-6 cervical disc showed anterior translation of the superior part of the graft.Intra-op imaging is not provided.This device was explanted 18 days after surgery.It would be helpful to see the initial orientation." if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: after reviewing the event description and checking the part no failure could be noted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6953991
• Report Number: 1030489-2017-02215
• Device Sequence Number: 10949050
• Product Code: MJO
• UDI-Device Identifier: 00613994493712
• UDI-Public: 00613994493712
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2024
• Device Catalogue Number: 6972450
• Device Lot Number: 0513159W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 10/24/2017; 02/27/2018
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 10/26/2017; 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 67