MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SOL5.5/6.0

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/23/2023

Event Type  Injury  

Event Description

Information was received from a healthcare professional via a manufacturer representative regarding a patient with preoperative diagnosis for t3-l2 fixation was performed in a case of scoliosis.Procedure performed was t2-l2 scoliosis (symptomatic) correction/fixation.Level at which implant was performed was t2-l2.It was reported that the t3 right pedicle hook was overstressed during the correction, the pedicle broke, so the fixation was extended to t2.When the right t2 screw was inserted, the screw could no longer be removed from the driver.Tried to replace the driver, but the screw did not remove.When the screw itself was replaced, it could be smoothly installed and removed.There was no patient symptoms or complications as a result of this event.There was a delay of less than 60 minutes.When the screw was inserted to the right of t2, the screw could not be removed from the driver, but it could be removed somehow by using a release paper to set the lock lever up.Afterward, in order to change the direction of the t2 right screw, when reinsertion was performed, the screw was attached to the screwdriver outside the patient's body, and when an attempt was made to see whether it could be removed, it was completely locked and did not come off.As stated, "the t3 right pedicle hook was overstressed during correction, resulting in pedicle breakage".T3 right pedicle hook: solera 5.5/6.0 hook , product was disposed of <(>&<)> it was not defective.If not forcefully, the screw is not removed.The switch part was peeled off and then forcedly opened using the principle of the needle.It did not come off the next time.The user error is suspected.In the end, the pedicle arch was damaged by the hook, but due to excessive force when the rod was tightened, it is believed that hook damaged the pedicle arch.

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.510 (k) is unknown as product identifiers are unknown.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 16766538
• MDR Text Key: 313559047
• Report Number: 1030489-2023-00277
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SOL5.5/6.0
• Device Catalogue Number: MSB_UNK_SOL5.5/6.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other