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

Model Number 7510200

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/20/2020

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 a health care provider via a manufacturer representative regarding a patient for spinal therapy.It was reported that the bmp did not grow any bone at all multiple failure in 2 sites.He says he has never had this problem before, he uses bmp at least 3 times a month.The surgeon also wanted to known if the bmp doesn't work with the medicines the patient is taking.2020-august-12, e2,(rep): additional information received states that the patient is suffering from acute and chronic sinusitis, j01.00, j32.0, as well as bone graft infection, t86.832, foreign body, reaction, t18.0xxa, and infection from internal fixation devices, t84.69xa.The patient had both caldwell luc as well as vertical sinusotomies, cpt 31030, 31020.Surgeon also removed the failed implants, cpt 20680, and performed bone grafts, bilaterally, cpt 21210 after debridement, cpt 11012.The infuse was implanted into the patient's maxilla and into the lateral sinus walls, bilaterally.There was no postoperative symptoms from the procedure and no tissue edema or fluid retention.The grafts did not succeed.The progress of the case has been copied to all of the patient's treating doctors.The status of the product was usual and customary.The patient is taking xeljanz, 5mg for treatment of an auto immune disease and surgeon suspect this is affecting the reactive nature of the body and the osteoblastic activity in the cancellous bone.

Manufacturer Narrative

B5/b7: 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.

Event Description

Information was received from a health care provider via a manufacturer representative regarding a patient for spinal therapy.It was reported that the bmp did not grow any bone at all multiple failure in 2 sites.He says he has never had this problem before, he uses bmp at least 3 times a month.The surgeon also wanted to known if the bmp doesn't work with the medicines the patient is taking.Additional information received states that the patient is suffering from acute and chronic sinusitis, j01.00, j32.0, as well as bone graft infection, t86.832, foreign body, reaction, t18.0xxa, and infection from internal fixation devices, t84.69xa.The patient had both caldwell luc as well as vertical sinusotomies, cpt 31030, 31020.Surgeon also removed the failed implants, cpt 20680, and performed bone grafts, bilaterally, cpt 21210 after debridement, cpt 11012.The infuse was implanted into the patient's maxilla and into the lateral sinus walls, bilaterally.There was no postoperative symptoms from the procedure and no tissue edema or fluid retention.The grafts did not succeed.The progress of the case has been copied to all of the patient's treating doctors.The status of the product was usual and customary.The patient is taking xeljanz, 5mg for treatment of an auto immune disease and surgeon suspect this is affecting the reactive nature of the body and the osteoblastic activity in the cancellous bone.History of present illness: on (b)(6)2020 the patient was scheduled for a 92 day followup.The patient has had multiple surgeries for an acute and chronic sinusitis.The patient's left side was surgerized on (b)(6)2019 because she had some implants placed by another practitioner and during that time they performed a sinus graft, during which bone was placed that extended to the floor of her left orbit and required considerable resection through a caldwell-luc approach to remove the infected bone that was in the maxillary aerated sinus.The patient also had the implants removed at that same time and the site was bone grafted with m dbx human bone putty.The patient had an oral antral fistula that was not healing on the patient's right side and the patient also did not respond well to the mtf dbx that was placed into her sinuses.Following this another surgery was performed on (b)(6)2020 and the patient had both maxillary sinuses and the maxilla, bilaterally, bone grafted with rhbmp, infuse, by medtronic.The patient was sent out for a new ct study to assess the healing as she still had symptoms of the sinusitis.This new ct study as well as an mri were performed on or about (b)(6)2020.The ct study was interpreted by dr.(b)(6), the chief of radiology at (b)(6)medical center.She also interpreted an mri that was performed in the same facial bones.In the maxilla, the patient has caldwell-luc deformities bilaterally and the caldwell-luc deformity on the left is new and she indicates there has been interval debridement with resection.Of the previously seen bone graft failures.The oral antral fistulas identified in the region of the left maxillary second premolar and first molar where the implants have been removedis present and there is a small amount of amalgamated bone graft material seen along the left maxillary alveolar ridge in the expected region of the second molar.There is now only mild mucoperiosteal thickening in the left maxillary sinus, representing a significant interval improvement.The right caldwell- luc deformity is unchanged.Bone graft material was seen along the right maxillary alveolar ridge as previously noted from her previous treatment with another practitioner and that is somewhat more amalgamated.There is a defect within the right maxillary alveolar ridge in the expected region of the second and first molar.There is a marked mucoperiosteal thickening and complete opacification of the right maxillary sinus.This has progressed since the prior study.But again just as a note there has been improvement in the left maxillary sinus.So there is a worsening sinusitis in the patient's right side.Spoke with dr.(b)(6), the patient's ent and after the mtf dbx was placed on (b)(6)2019 on the left side, (b)(6)2019 on the right side and then the rhbmp was placed on (b)(6)2020 bilaterally.Additional information was received from patient via representative stated that she has not taken the xeljanz since (b)(6) 2019.

Event Description

Information was received from a health care provider via a manufacturer representative regarding a patient for spinal therapy.It was reported that the bmp did not grow any bone at all multiple failure in 2 sites.He says he has never had this problem before, he uses bmp at least 3 times a month.The surgeon also wanted to known if the bmp doesn't work with the medicines the patient is taking.Additional information received states that the patient is suffering from acute and chronic sinusitis, j01.00, j32.0, as well as bone graft infection, t86.832, foreign body, reaction, t18.0xxa, and infection from internal fixation devices, t84.69xa.The patient had both caldwell luc as well as vertical sinusotomies, cpt 31030, 31020.Surgeon also removed the failed implants, cpt 20680, and performed bone grafts, bilaterally, cpt 21210 after debridement, cpt 11012.The infuse was implanted into the patient's maxilla and into the lateral sinus walls, bilaterally.There was no postoperative symptoms from the procedure and no tissue edema or fluid retention.The grafts did not succeed.The progress of the case has been copied to all of the patient's treating doctors.The status of the product was usual and customary.The patient is taking xeljanz, 5mg for treatment of an auto immune disease and surgeon suspect this is affecting the reactive nature of the body and the osteoblastic activity in the cancellous bone.History of present illness: on (b)(6) 2020 the patient was scheduled for a 92 day followup.The patient has had multiple surgeries for an acute and chronic sinusitis.The patient's left side was surgerized on (b)(6) 2019 because she had some implants placed by another practitioner and during that time they performed a sinus graft, during which bone was placed that extended to the floor of her left orbit and required considerable resection through a caldwell-luc approach to remove the infected bone that was in the maxillary aerated sinus.The patient also had the implants removed at that same time and the site was bone grafted with m dbx human bone putty.The patient had an oral antral fistula that was not healing on the patient's right side and the patient also did not respond well to the mtf dbx that was placed into her sinuses.Following this another surgery was performed on (b)(6) 2020 and the patient had both maxillary sinuses and the maxilla, bilaterally, bone grafted with rhbmp, infuse, by medtronic.The patient was sent out for a new ct study to assess the healing as she still had symptoms of the sinusitis.This new ct study as well as an mri were performed on or about (b)(6) 2020.The ct study was interpreted by dr.(b)(6), the chief of radiology at (b)(6) medical center.She also interpreted an mri that was performed in the same facial bones.In the maxilla, the patient has caldwell-luc deformities bilaterally and the caldwell-luc deformity on the left is new and she indicates there has been interval debridement with resection.Of the previously seen bone graft failures.The oral antral fistulas identified in the region of the left maxillary second premolar and first molar where the implants have been removedis present and there is a small amount of amalgamated bone graft material seen along the left maxillary alveolar ridge in the expected region of the second molar.There is now only mild mucoperiosteal thickening in the left maxillary sinus, representing a significant interval improvement.The right caldwell- luc deformity is unchanged.Bone graft material was seen along the right maxillary alveolar ridge as previously noted from her previous treatment with another practitioner and that is somewhat more amalgamated.There is a defect within the right maxillary alveolar ridge in the expected region of the second and first molar.There is a marked mucoperiosteal thickening and complete opacification of the right maxillary sinus.This has progressed since the prior study.But again just as a note there has been improvement in the left maxillary sinus.So there is a worsening sinusitis in the patient's right side.Spoke with dr.(b)(6), the patient's ent and after the mtf dbx was placed on (b)(6) 2019 on the left side, (b)(6) 2019 on the right side and then the rhbmp was placed on (b)(6) 2020 bilaterally.Additional information was received from patient via representative stated that she has not taken the xeljanz since (b)(6) 2019.Additional information was received from hcp via representative state that the patient had failed dental fusion with implant.The physician request was if xeljanz could influence bone remodeling as the patient stated they were taking this medication, but also said they were not taking it.Dr.Wolff was unsure.A literature search did not reveal any previous interaction with infuse or bone remodeling.The physician will inquire with pfizer, the manufacture of xeljanz to see if they have information in this regard.The patient has ulcerative colitis.

Manufacturer Narrative

B5/b7: 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: 10440873
• MDR Text Key: 209401502
• Report Number: 1030489-2020-01127
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 7510200
• Device Catalogue Number: 7510200
• Device Lot Number: M111809AAJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/12/2020; 09/16/2020
• Supplement Dates FDA Received: 09/04/2020; 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 71