MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE CONTROL PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 5011022

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with a fusion therapy.It was reported that 19 years ago, correction and plif was performed for spondylolisthesis occurred at l5/s.This time, the vertebral body of l4/5 slipped 40 degrees, so it was necessary to correct and fix.It was the reoperation for the operation performed for correcting spondylolisthesis occurred at l5/s.At first, it was planned to place a reduction screw at l4 and perform rodding by continuing using m8 at l5 and s, but the physician wanted to use the screw with movable head, so it was decided to replace the screw at l5 just before the operation.However, the break-off of the set screw on one side was notperformed, so the rod was removed and solera was used instead.There was a delay in procedure for less than 60 minutes.Plif was performed, but the cage on one side had been placed while the patient was lying down because before rotating, the screw could not be reattached after it was removed.It was suggested to take out the cage once and then insert it again and place it after turning it 90 degrees.But the physician said that it was okay if a spacer could be placed, so the procedure was performed as the physician's judgment.It was the case that the cage could not be rotated on the one side of l5.After the screw was inserted, the pedicle was cut out during rodding and bleeding occurred.The screw was replaced.The surgeon wanted to place the screw at s as it was, but the set screw did not engage well and it had to replace the screw.Product was explanted.The device will not be replaced and there was no fragment left or contact with the patient.There were no symptoms reported.There were no further complications reported regarding the event.

• Brand Name: CAPSTONE CONTROL PTC SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10269615
• MDR Text Key: 200000651
• Report Number: 1030489-2020-00898
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5011022
• Device Catalogue Number: 5011022
• Device Lot Number: H5453576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention