MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ZEVO ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	7713513
Medical Device Problem Codes	Break (1069); Expulsion (2933)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
It was reported that the patient underwent anterior cervical discectomy and fusion at c3-c7, in which the plate and screws were implanted.On an unknown date, post-op, two inferior screws at c7 backed out.The locking mechanism on the c7 screws broke as well.Hence, on an unknown date, a revision surgery was performed, in which the alleged screws were explanted.No fragment of the alleged screws remained inside the patient.The plate was not explanted.No patient complications were reported as a result of this event.

• Brand Name: ZEVO ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9843644
• Report Number: 1030489-2020-00319
• Device Sequence Number: 10947798
• Product Code: KWQ
• UDI-Device Identifier: 00643169329294
• UDI-Public: 00643169329294
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141632
• 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
• Report Date (Section B): 03/17/2020

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 Catalogue Number: 7713513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/17/2020
• 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