MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC OSTEOCOOL BONE ACCESS KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number OCN002

Device Problem Difficult To Position (1467)

Patient Problems Paralysis (1997); Spinal Cord Injury (2432)

Event Date 08/14/2017

Event Type  Injury  

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with the following pre-operative diagnosis: metastatic malignant lesion to thoracic level 8 vertebral body.He underwent the following procedure: t8 bone tumor ablation with a kyphoplasty.During the procedure, the surgeon began by accessing the left side of the vertebral body with a transpedicular approach.This was done successfully.The surgeon then began accessing the right side of the vertebral body with an extra-pedicular approach.He struggled with this access and his percutaneous 10 gauge needle kept slipping off.He spent several minutes trying to get the bone access needle to seat into the pedicle.It should be noted that during this access, he requested the x-ray technologist to take an ap and a lateral picture.These images showed that his bone access needle was in the disc above the vertebra that was being operated on (t8 was being operated).In the ap, the needle in the disc was just past the medial border of the right pedicle from a lateral to medial perspective.The lateral im age showed that the needle was just a few mm deep in the disc.When correlating these two images, the bone access needle was in the right intervertebral foramen between t8 <(>&<)> t7.At the time these two pictures were taken.The scrub technologist looked concerned with the images.The surgeon then made several needle repositioning adjustments (3-5) trying to get the needle to seat on bone and then pulled the needle out of the patient to start over again on the right side.According to sales rep¿s opinion, this is when the injury might have occurred to the patient, however at the time it was unknown that there was even an injury.After the surgeon accessed the vertebral body on the right side, he drilled to the anterior border of the vertebral body and in the ap image, the tip of the drill was on midline.After drilling on both sides, he positioned the needles anterior in the vertebral body and used the mapping drill to confirm that he could safely ablate with a 10 mm probe.He ran an ablation sequence anterior in the vertebral body and then pulled the needles posteriorly such that the needle tips were still within the vertebral body, drilled to measure again to confirm the 10 mm probe sizing and ran a second ablation sequence.After the ablation, the surgeon finished the case by performing a kyphoplasty and closing.There were no malfunctions reported for any of the instruments.All tool and equipment instructions were followed during the procedure.The patient was to be operated on as an outpatient.Post-op, when the patient reported paralysis of lower extremities after waking up, he was immediately sent to have an mri done and then was admitted as an inpatient.Prolongation of existing hospitalization was necessary as the result of post-op complaints.There was no edema noted on the post operative mri, and the surgeon described the post-operative mri in regards to the patient's spinal cord as "pristine".A follow-up mri was performed 24 hours later at which time the patient was diagnosed as having suffered a spinal cord stroke.He was then discharged to a medical rehabilitation facility a number of days later.The event was reported as related to the procedure.It is unknown whether the patient symptoms have persisted or improved.

• Brand Name: OSTEOCOOL BONE ACCESS KIT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6854402
• MDR Text Key: 85605351
• Report Number: 1030489-2017-02022
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2018
• Device Catalogue Number: OCN002
• Device Lot Number: WI469106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2016
• 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
• Treatment: PROBE
• Patient Outcome(s): Other
• Patient Age: 70 YR