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

Catalog Number	6972660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/17/2017
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
Procedure: cervical arthroplasty that ended up being an anterior cervical discectomy and fusion (acdf) it was reported that after opening the box during surgery, surgeon realized that the height of the implant was too much.The procedure was changed from arthroplasty to acdf.No malfunction of the implant was reported.The surgery was completed with another implant.
Additional Manufacturer Narrative
Product analysis: implant not implanted into the patient.No complaint or non-conformance alleged or identified with regard to the returned product.After visual review, no evidence was found that would suggest a defect in manufacturing or processing the implants appear to be capable of performing their intended function.

• 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: 6632931
• Report Number: 1030489-2017-01525
• Device Sequence Number: 613954
• Product Code: MJO
• UDI-Device Identifier: 00613994493668
• UDI-Public: 00613994493668
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2022
• Device Catalogue Number: 6972660
• Device Lot Number: 0350490W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 07/25/2017
• 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: Other