MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON SOLERA 4.75; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 54740004540

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog #54840004540 with 510k #k091974 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 healthcare professional via manufacturer representative regarding a patient with a pre-operative diagnosis of t12 rupture fracture, utilizing a device for spinal therapy.Levels implanted : t11 it was reported that after the screw was inserted, the screw head was locked in the operating field.The screw broke.No fragment was remaining in the patient's body.The device was explanted.After the reported screw was removed, a new screw was inserted.There was a delay in the surgery by less than 60 mins.No health damage in the patient was reported.No further complications were reported regarding the event.Update : after the reported screw was inserted, doctor checked the mobility of the screw head by hand.But it did not move, so it was removed, even though it was checked outside operating field again, but the mobility was stiff.Therefore, it was not used, and a new one was opened and used.It was viewed by the doctor that there was no problem in particular before attaching to the driver.Update: the product came in contact with the patient.

Manufacturer Narrative

H3: product analysis: part # 55740004540; lot # h5487511 visual and optical inspection did not reveal any damage to the head and crown of the screw.Functional inspection confirmed the screw head was locked in an angled position and was not able to pivot in any direction.The crown has been pushed down through the saddle of the screw not allowing the head to pivot anymore.This is a normal issue when the bone screw is implanted and a rod is seated in the crown and tightened.The pivoting head was loosened.The screw appears to function as intended.No fault found.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 SOLERA 4.75
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 11383171
• MDR Text Key: 233793878
• Report Number: 2647346-2021-00010
• Device Sequence Number: 1
• Product Code: NKB
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54740004540
• Device Catalogue Number: 54740004540
• Device Lot Number: H5487511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• 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 Sex: Female