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

Catalog Number	6972660
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Headache (1880); Inadequate Pain Relief (2388); Neck Pain (2433)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2014, the patient underwent surgery at levels c6-c7; c4-c5 with implantation of artificial cervical disc at level c6-c7 due to pre-op diagnosis: neck pain, disc herniation.On (b)(6) 2014, the patient underwent anterior cervical disc fusion(acdf) surgery at levels c4-c5,c5-c6,c6-c7 with implantation of another artificial cervical disc.On (b)(6) 2017, the patient underwent a revision surgery in which both the discs implanted were removed.The surgeon stated that the patient had a brief period of neck pain relief but that the neck pain has continued and the patient was also experiencing occipital headaches.Discs were being removed due to persistent neck pain.Removal of both discs were uncomplicated but surgeon noted some heterotopic ossification (grade 1) posterolateral to artificial disc replacement device."ho" was removed with drill.The artificial disc replacement device plus peri-prosthetic tissue was sent for analysis per fda requirements.Revision treatment included three level using peek plus anterior plate.Tissue ingrowth was observed between superior and inferior device components.Metal debris was visible in tissue lateral to lp device.The current status of patient is unknown but patient did recover from revision surgery.
Additional Manufacturer Narrative
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.

• 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: 6309841
• Report Number: 1030489-2017-00260
• Device Sequence Number: 38923
• Product Code: MJO
• UDI-Device Identifier: 00613994493668
• UDI-Public: 00613994493668
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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: 09/18/2022
• Device Catalogue Number: 6972660
• Device Lot Number: 0327210W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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
• Patient Age: 44 YR
• Patient Weight: 109