MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7577545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
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 about 3 years back, the patient underwent minimal invasive transforaminal lumbar interbody fusion (mis-tlif) at l5-s1.Cage (from velofix vendor), screws and rods were implanted in the patient during this surgery.On an unknown date, a year and 4 months post-op, the patient presented with non-union.Reportedly, the patient started to hear noises (clicks) in his back and the patient had a lot of pain in his back.Reportedly, there was fusion at only one side; and likely, the cage was small due to which there was a little gap between vertebrae.Hence, the patient underwent an anterior lumbar interbody fusion (alif) to replace the cage implanted in the previous surgery.In this surgery, the cage was replaced with a newer and a bigger one, in which more amount of bone material was placed.The patient started to feel better after alif, but there was still pain in the patient's back.The patient still heard click noises in his back.So, a year later, another surgery was performed, in which removal of screws and rods was performed.It was found that the area where the patient was experiencing pain, was the same place at which the screw broke.The broken screw could not be removed from the patient during this surgery.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 10075301
• Report Number: 1030489-2020-00537
• Device Sequence Number: 3218275
• Product Code: KWP
• UDI-Device Identifier: 00885074032047
• UDI-Public: 00885074032047
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: 7577545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/20/2020
• 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