MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INDUCTOS; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number MSB_UNK_INDUCTOS

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

Patient Problems Bacterial Infection (1735); Eye Injury (1845); Fatigue (1849); Fever (1858); Low Blood Pressure/ Hypotension (1914); Undesired Nerve Stimulation (1980); Pain (1994); Blurred Vision (2137); Dizziness (2194); Hypoesthesia (2352); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Fluid Discharge (2686); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 06/23/2021

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.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.

Event Description

Information received from patient, distributor via manufacturer representative regarding an event happened during post-op of the reported product.It was reported that, procedure identified by patient as spinal fusion of l4-s1, posterior approach.Mis plf with robotic navigation.It was 2 days post op - patient complained to surgeon of severe rhs leg pain - initially intermittent but escalating in frequency and severity.Pain progressed to loss of feeling in rhs calf/foot and big toe.Expressed concern about pain to the surgeon and was told that the procedure had been a success.Patient stated, she was then put under the care of the nurses.Since discharge pain has continued.Patient has experienced disturbed sleep/insomnia - but patient doesn't feel it is linked to pain.Patient went up to 2 days without sleep and experienced 10 days with disrupted sleep pattern, sleeping for up to 15 mins at a time.At a point after discharge (but before physiotherapy started) patient complained of local swelling of surgical site, suspected surgical infection.Patient underwent tests (negative results).Patients wound continued to be healing well but then swelled and wound reopened with discharge.Patient was diagnosed with strep b infection.Infection resolved with antibiotics.Patient started physiotherapy approx.2 months post op.And later, reported starting with eye pain and dizziness.Patient was sent to eye clinic, reports feeling dizzy and requiring support to stay upright.¿felt like falling¿.Patient not diagnosed with vertigo.Patient¿s vision ¿became blurry¿.Patient was readmitted due to an uneven pupil response and was given ¿brain mri¿ but, the mri results were not disclosed.Patient reports living with rhs leg, hip and knee pain, and a sharp occasional (¿nerve¿) pain in foot.Patient continues to experience dizziness and sleep problems.No further complications reported.

Manufacturer Narrative

Updated information: b5, h6.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.

Event Description

Additional information received.Patient reported additional symptoms i.E., fatigue, frozen pupil, permanent vision deterioration, fever, spinal arch discontinuation, nerve pressure, low blood pressure.No further complications reported.

Manufacturer Narrative

Correction: b1 is corrected to adverse event.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: INDUCTOS
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• 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: 15025869
• MDR Text Key: 295954309
• Report Number: 1030489-2022-00648
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_INDUCTOS
• Device Catalogue Number: MSB_UNK_INDUCTOS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2023
• 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): Hospitalization
• Patient Sex: Female