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

Catalog Number	6972860
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Pre-operative diagnosis- cervical stenosis procedure- cervical disc replacement levels implanted- c4-5 it was reported that, post-op, the device was dislodged.The product came in contact with the patient.No patient complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Through radiographics image, it was confirmed that revision surgery was performed on (b)(6) 2019.

• 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: 8454984
• Report Number: 1030489-2019-00323
• Device Sequence Number: 429822
• Product Code: MJO
• UDI-Device Identifier: 00613994493637
• UDI-Public: 00613994493637
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2026
• Device Catalogue Number: 6972860
• Device Lot Number: 0659380W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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: Required Intervention