MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 5430030

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Delay in procedure over 60 minutes.This part is not approved for use in the united states; however a like device catalog # 5440030, 510k # k102555 and udi # (b)(4) was cleared in the united states.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of paralytic scoliosis, undergoing a spinal therapy.It was reported that, for placing the anchor at the liv, fas 4.0 x 25 was inserted into each side of l4/5.The rod was placed and set screw was placed with a provisional driver while hanging the counter to prevent rotation.At that time, it was felt that it was difficult to remove the counter and the counter was managed to be removed somehow.The procedure was proceeded as it was.After that, rod was placed on the opposite side, and the crosslink was placed.The crosslink tightening was performed first.After that, screw break-off on the right was performed, and finally on the left, an event occurred.Even though it was attempted to perform break-off, the product idled.Even though the set screw was changed several times, the set screw could not be broke off.The screw loosened due to this process and it made the screw unusable.The screw was changed to two 5.5 x 25 mm, and rod was placed, crosslink was placed, break-off was tried from the screw, and tightening was performed without problems.Then crosslink was tightened.There were no patient symptoms or complications as a result of this event.There was a delay of over 60 minutes.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.Patient medical history: brain paralysis procedure: glowing rod, anchor placement.Set screw was idled and tightening could not be performed at the time of final tightening for the two screws.Therefore, when they replaced the screws and set screws, it was able to finally fasten them without any problems.When setting the rod (titanium alloy) on the screw head, it did not appear to be particularly loaded.Also, when setting the same rod after replacing the screw, bending was not performed.The counter was used, and it was difficult to remove it after temporary fixing, and it was difficult to attach it to the screw head at the time of final tightening.The sales rep raised this report desiring for inspecting the product and the content of the malfunction.The malfunction is unknown at this point.Regarding the set screw, there might be burr on the set screw.This was not a revision surgery.In the same operation, when inserting the implants, malfunction occurred, so the implants were removed and replaced with other implants.Levels implanted: th2/3 and l3/4.

Manufacturer Narrative

Product analysis part # 5430030, lot # h5490534.Visual and macroscopic inspection revealed the threads of the set screw have been damaged.The damage is evident around the entire crest of the threads.This damage appears to have initiated at the start of the thread and is consistent around the damaged portions of the thread.The upper break off portion of the screw is still attached.This type of damage is consistent with misalignment of the mas and set screw threads during construct assembly.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: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 11926507
• MDR Text Key: 254051443
• Report Number: 2647346-2021-00031
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5430030
• Device Catalogue Number: 5430030
• Device Lot Number: H5490534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• 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
• Patient Age: 4 YR
• Patient Sex: Female