MAUDE Adverse Event Report: ZIMMER SPINE VISTA CAGE; INTERVERTEBRAL FUSION DEVICE

Lot Number P032329

Device Problems Break (1069); Material Fragmentation (1261); Loose or Intermittent Connection (1371)

Patient Problems Eye Injury (1845); Pain (1994); Swelling (2091); Device Embedded In Tissue or Plaque (3165)

Event Date 04/24/2015

Event Type  Injury  

Event Description

Reporter states that on (b)(6) of 2006, he had visita cage put in his back.He says he was unable to lie down still on the operating table during the seven hours procedure due to excruciating pain which led to the dr restraining and medicating him.Upon completion of the procedure, reporter states that he experienced shoulder pain, black eye and swollen lips as a result of the restrain.Reporter says he suffered persistant pain for nine months which led to another surgery on (b)(6) 2006 to address the pain.According to the reporter and based on info he got from the second dr, the cage was broken with loose rods and had to tighten rods with add'l screws.Reporter says he felt better for a couple of months and went immediately back to his initial pain level due to a car accident that helped loosen the rods once more.Reporter says rods were removed but the cage was left and according to the dr, "everything seems to be good, cage is intact." but on (b)(6) 2014, reporter got into another accident and was taken back to the very first (b)(6)/hospital.Reporter says he showed the dr the pictures of the broken cage that was repaired by another dr and this got the dr very upset and asked him to leave his office.Reporter says he then resorted to his family dr who requested for a ct scan of l4, l5 and s1.The scan was done on (b)(6) 2015 and that the lady who did the scanning expressed concern as to the number of holes and the extent of the broken cage.Reporter says he believed that during the second repair, an undocumented titanium bearings were placed to support the broken cage.Reporter says the reason for this assumption is based on the metal flashing device that was placed between the undocumented bearings/cage by dr (b)(6) who performed the repair.This metal flashing device was able to be detected through the use of a 3d imaging that was requested by a third dr.Reporter says the undocumented broken cage is jagging against his aorta and believes his life is in serious danger as anything can happen.

• Brand Name: VISTA CAGE
• Type of Device: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): ZIMMER SPINE
• MDR Report Key: 7156875
• MDR Text Key: 96314509
• Report Number: MW5074315
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: P032329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 100