MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	5011022
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
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 presented with lumbar spinal canal stenosis and l3-l4 spondylolisthesis.She underwent l3-l4 transforaminal lumbar interbody fusion (tlif) and l4-l5 posterior lumbar interbody fusion (plif).Intra-op, after performing plif at l4-l5, the cage was found deviated forward when checking the sagittal images.The surgeon then tried to grasp the posterior side of the cage with inserter¿s inner cylinders, pean and kocher while checking the sagittal images; however, the cage advanced forward and stood upright in the anterior vertebral body.The surgeon judged that it was hard to remove the cage from the posterior side.Hence, new cage was inserted at the intervertebral disc space and compression was applied and the operation was completed.There was a delay of less than 60 minutes in overall procedure time due to this event.It is unknown if there were any patient complications.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was unknown if there will be any intervention required.

• Brand Name: CAPSTONE CONTROL PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8952933
• Report Number: 1030489-2019-00960
• Device Sequence Number: 2099918
• Product Code: MAX
• UDI-Device Identifier: 00643169677500
• UDI-Public: 00643169677500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171107
• 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): 09/01/2019

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: 5011022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 09/01/2019
• Supplement Report FDA Received Date: 09/01/2019
• 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