MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number MSB_UNK_BMP2_ACS

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

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient via a manufacturer representative for spinal therapy.It was reported that the patient had cervical fusion on c5 and c6.She was send home in a walker, leg and foot were not functioning correctly, put her as a fall risk because of medication she was on after surgery.Leg and foot still not functioning correctly; extreme pain; also affecting right arm; constant body temperature changes.While reading through records, she discovered that they had fractured her vertebrae.No one told her of this after surgery.When she contacted the doctor, he said all her issues were neurological, but she¿s seen a neurologist, and was told no neurological problems.There were no further complications reported regarding the event.Additional information was received from consumer via company representative states that her surgery date was (b)(6) 2019.However she cannot confirm that infuse was used in her surgery.Patient was asked for her operative report and implant log, which she said she would send.She believes infuse was used off-label and states she got that information from searching on-line (internet).She said she had all the side effects that were listed on the internet, so she was certain infuse was used.She did not provide additional information.

Event Description

Information was received from a patient via a manufacturer representative for spinal therapy.It was reported that the patient had cervical fusion on c5 and c6.She was send home in a walker, leg and foot were not functioning correctly, put her as a fall risk because of medication she was on after surgery.Leg and foot still not functioning correctly; extreme pain; also affecting right arm; constant body temperature changes.While reading through records, she discovered that they had fractured her vertebrae.No one told her of this after surgery.When she contacted the doctor, he said all her issues were neurological, but she¿s seen a neurologist, and was told no neurological problems.There were no further complications reported regarding the event.Additional information was received from consumer via company representative states that her surgery date was (b)(6) 2019.However she cannot confirm that infuse was used in her surgery.Patient was asked for her operative report and implant log, which she said she would send.She believes infuse was used off-label and states she got that information from searching on-line (internet).She said she had all the side effects that were listed on the internet, so she was certain infuse was used.She did not provide additional information.Additional information was received from consumer via company representative states that she also says she found her neck and hand w ere fractured during surgery and she found out after.Had a cervical fusion 4, 5, 6 in (b)(6) 2019 to resolve ridiculothopy.She is having traveling pain that is affecting her mobility.She feels her hcp and surgeon have not been straight forward with her and has had difficulty obtaining her records and has felt at times her records were altered to the interest of the hcp.She is very concerned with how her case has been handled.She feels her doctor is being difficult in giving her care and bullying his facility to only use stryker products 75% of the time.Additional information was received from consumer via company representative states that she believes that infuse bone graft was used in a cervical spine however she is not able to find any documentation to support that.She has reached out to her surgeon however it appears he has fired her from the practice.She also went to a second or a surgeon but she said he lied to her and she's no longer seeing him.She is basing her information from a loaner consignment form that she found where a 133 number was used on the form.She is convinced that this is a chinese number for an old infuse bone graft number and that should not have been used in her surgery.The number she is referencing is a case #- not a product number.She claims that the hospital has sent her a letter and the hospital denied that infuse bone graft was used in her surgery.She thinks they're lying.There is no mention according to the patient of infuse bone graft being used in her operative report.

Manufacturer Narrative

B5, b7, h6 : additional information 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.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10578950
• MDR Text Key: 208381253
• Report Number: 1030489-2020-01336
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BMP2_ACS
• Device Catalogue Number: MSB_UNK_BMP2_ACS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other