MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ZEVO ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	G7703515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the broken screw could not be confirmed.However, it was one from the following 4 lot numbers: h5525799, h5372141, h5487785 or h5438715.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported 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 fixation of c3-c6 due to cervical spondylotic myelopathy.Intra-op, the head of the screw at c4 broke during insertion.The head part of the broken screw was successfully removed from patient's body.Only the shaft of the screw remains implanted in the patient body as it was very difficult to remove.No injury to the patient was reported.
Additional Manufacturer Narrative
X-ray review results: post-op x-rays of c3-c6 anterior cervical discectomy and fusion were received.By report, the screws at c4 are broken at the head and only screws are left in the vertebral body.In the lateral x-ray, they appear to be fairly cranially oriented but look to be within the range of tolerance for angulation.Hardware placement otherwise appears appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZEVO ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8677868
• Report Number: 1030489-2019-00609
• Device Sequence Number: 2003962
• Product Code: KWQ
• UDI-Device Identifier: 00643169398481
• UDI-Public: 00643169398481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: G7703515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR