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

Catalog Number	6961470
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Cerebrospinal Fluid Leakage (1772); Weakness (2145); Device Embedded In Tissue or Plaque (3165)
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: superficial siderosis level implanted: c3-c4 it was reported that the patient underwent anterior cervical discectomy and arthroplasty surgery.Post-op, one screw of the disc broke and distal tip was not retrieved.Removal of device and fusion of index level was a revision surgery that was performed.Surrounding product tissue prior and after to explanation was blackened.Broken fragment remains in the patient.General increasing weakness and imaging confirmed diagnosis of siderosis as a patient complication.Patient symptoms may be caused by leakage of chronic csf leak during the procedure.
Additional Manufacturer Narrative
Product analysis result: visual microscopic the disc was returned with 3 screws and one locking tab.One of the screws was broken ~5mm from the tip.The tip of the fractured screw was not returned for analysis.The distal portion of the screw was examined microscopically, there did not appear to be signs of fatigue.The outside surface of the screw was examined and there did not appear to be any surface defects that would have caused the crack propagation.The wear pattern on the ball of the disc indicates that the inferior portion of the disc was sitting proud for some time.There is a witness mark on the superior portion of the disc where the edge of the screw had been touching.After examining the fracture face of the failed screw it appears the fracture was the result of overload through non-torsional force.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: 8450276
• Report Number: 1030489-2019-00318
• Device Sequence Number: 16853924
• Product Code: MJO
• UDI-Device Identifier: 00721902723254
• UDI-Public: 00721902723254
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P060018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 05/24/2019

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: 02/25/2013
• Device Catalogue Number: 6961470
• Device Lot Number: W08B2382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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: Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 70