MAUDE Adverse Event Report: WARSAW ORTHOPEDICS MSB CD HORIZON SOLERA SPINAL SYSTEM; ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION

Model Number 1664017

Device Problems Mechanics Altered (2984); Noise, Audible (3273)

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

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional via manufacturer representative regarding a patient with an indication of spinal canal stenosis in need of spinal posterior fixation (lumbar) spinal therapy.It was reported that after performing olif at l4/5, position was changed to posterior position, and tlif was performed at l5/s.While psf was performed at l4/s, after placing the right rod, the left rod was inserted and fixed provisionally with set screws.The sound of tightening from the time of provisional fixing was strange, during the final tightening, the set screws idled and could not be broken off.When the set screws were newly replaced and the angle of the screw heads were changed a little and it was tried to break off the screws again, the screws were broken off, so the procedure was completed.There was a delay of less than 60 mins in overall procedure time reported.There were no patient symptoms reported.There were no fragments in the patient reported.There were no further complications reported regarding the event.

Manufacturer Narrative

H3.Device evaluation summary: the tip of set screws were deformed, and the threads were damaged.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.

Manufacturer Narrative

Additional information: h3 h3.Device evaluation summary: after visual and optical examination, it appears that threads of the set screw are cross-threaded/damaged.This damage appears to have initiated at the start of the thread and is consistent around the damaged portion of the thread.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: MSB CD HORIZON SOLERA SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10354634
• MDR Text Key: 202600256
• Report Number: 1030489-2020-01016
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K943827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1664017
• Device Catalogue Number: 1664017
• Device Lot Number: 0775230W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 56