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

Catalog Number	8792815
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
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 patient underwent initial surgery due to inter-vertebral disc degeneration on (b)(6) 2016.On an unknown date, post-op, wire breakage was found and the implanted screw backed out.The location of fracture screw was in wire, about the neck, c5-6.The patient underwent revision surgery on (b)(6) 2017 to take out the screw.No patient complications were reported.
Event or Problem Description
It was reported that peek implant was not explanted but the screw was explanted.

• Brand Name: ZEPHIR ANTERIOR CERVICAL 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: 6342634
• Report Number: 1030489-2017-00331
• Device Sequence Number: 659191
• Product Code: KWQ
• UDI-Device Identifier: 00721902610660
• UDI-Public: 00721902610660
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2017

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 Catalogue Number: 8792815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided; 02/14/2017
• Initial Report FDA Received Date: 02/19/2017
• Supplement Report FDA Received Date: 03/13/2017; 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: 53 YR