MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number MSB_UNK_SCRW_LG 5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 09/07/2020

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

Event Description

Information was received from healthcare professional via field representative regarding patient with symptoms of restenosis involved spinal therapy.It was reported during procedure, when the head positioner was attempted to be used at the time of removal, noted the tip part was slightly slant and when they continued to use, the tip turned around and it was hard to use.Reported instrument broke and there were no fragments of instrument left in the patient¿s body.As the patient had restenosis, this instrument was used to remove the implanted product.Event was revision surgery.There was no delay in overall procedure time.There is no patient symptoms or complications reported as a result of the event.No health damage in the patient was reported.Received additional information that screw was explanted in the revision surgery and fenestration was performed.Reported there is no malfunction of reported screw.There is no patient problem reported after the surgery.

Manufacturer Narrative

Additional information: d7: explanted date is updated.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

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.

Event Description

Information was received from healthcare professional via field representative regarding patient with symptoms of restenosis involved spinal therapy.It was reported during procedure, when the head positioner was attempted to be used at the time of removal, noted the tip part was slightly slant and when they continued to use, the tip turned around and it was hard to use.Reported instrument broke and there were no fragments of instrument left in the patient¿s body.As the patient had restenosis, this instrument was used to remove the implanted product.Event was revision surgery.There was no delay in overall procedure time.There is no patient symptoms or complications reported as a result of the event.No health damage in the patient was reported.Received information that screw was explanted in the revision surgery and fenestration was performed.Reported there is no malfunction of reported screw.There is no patient problem reported after the surgery.On 2020-dec-09, received additional information that in the initial surgery the implanted level was (l4/5).Spinal canal stenosis did not occur due to legacy 5.5 screw.Spinal canal stenosis occurred at l3/4 that is one level higher than the implanted level.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 10592084
• MDR Text Key: 208716542
• Report Number: 1030489-2020-01348
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCRW_LG 5
• Device Catalogue Number: MSB_UNK_SCRW_LG 5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention