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

Model Number MSB_UNK_BMP2_ACS

Device Problem Off-Label Use (1494)

Patient Problems Wound Dehiscence (1154); Dehydration (1807); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Seroma (2069); Non-union Bone Fracture (2369)

Event Date 10/22/2023

Event Type  Injury  

Manufacturer Narrative

A2: age - mean age of 50 patients was 51.71 +/- 19.87 years (range of 17-83 years old).Citation: ramtin dastgir, joshua coffey, humzah quereshy, dale a.Baur and faisal a.Quereshy.Elsevier inc.2023.2212-4403/.Nonvascularized bone grafts: how successful are they in reconstruction of segmental mandibular defects?.Retrospective study.Doi.Org/10.1016/j.Oooo.2023.10.010.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

Citation: ramtin dastgir, joshua coffey, humzah quereshy, dale a.Baur and faisal a.Quereshy.Elsevier inc.2023.2212-4403/.Nonvascularized bone grafts: how successful are they in reconstruction of segmental mandibular defects?.Retrospective study.Doi.Org/10.1016/j.Oooo.2023.10.010.Event summary: the objective of this study was to assess the success rate of these grafts in reconstruction of segmental defects of various sizes in the mandible.The study demonstrated substantial success rate with non-vascularized bone grafts in reconstruction of segmental mandibular defects.This is a retrospective chart review study of mandibular segmental defects reconstruction using non-vascularized bone grafts at the department of oral and maxillo facial surgery at case western reserve university and university hospitals.Inclusion criteria of the study included: patients who had undergone reconstruction of segmental mandibular defects using non-vascularized bone grafts.Of the 131 patients who had meet the preliminary inclusion criteria, 50 wereeligible after application of the exclusion criteria with an age range of 17-83 years old (mean age of 51.71 +/- 19.87 years old).Bone morphogenetic protein (bmp) was utilized in 41 cases as an adjunct to aicbg, picbg, or allograft.Patients underwent secondary mandibular reconstruction with autogenous non-vascularized bone grafts following the initial resection of the defect.  reported event: complications were observed in 34% of cases, of which the most common complications were infection and wound dehiscence respectively.1.      age of patient at graft: 67.6 yrs with osteomyelitis, had non-union with allograft which was then complicated by introral non healing dehiscence at 19 months follow up.2.      age of patient at graft: 21.5 yrs with okc, had fibrous non-union grafted with allograft and two 2.0 plates at 80 months follow up.3.      age of patient at graft: 83.1 yrs with orn, had dehiscence-closed with repacking at 65 months follow up.4.      age of patient at graft: 62.1 yrs with scc, had dehydration/aki-treated at 38 months follow up.5.      age of patient at graft: 33.3 yrs with fibrous dysplasia lesion, had seroma of the hip treated with aspiration at 6 months follow up.6.      age of patient at graft: 17.4 yrs with ameloblastoma, had infection resolved with i<(>&<)>d/debridement/hardware removal at 78 months follow up.7.      age of patient at graft: 24.1 yrs with ameloblastoma, had infection drainage from neck-debridement, hardware removal and ex fix, regraft with bmp + recon plate at 8 months follow up.8.      age of patient at graft: 45.2 yrs with osteomyelitis, had infection and partial loss of graft, possible fibrous non-union at 72 months follow up.9.      age of patient at graft: 69.3 yrs with osteomyelitis, had parotitis (1month post-op resolved with abx) at 10 months follow up.10.   age of patient at graft: 44.9 yrs with ossifying fibroma, had dehiscence, infection, graft failure-removal, followed by free fibula graft at 7 months follow up.11.   age of patient at graft: 57 yrs with ameloblastoma, had infection, loss of graft fibula recon at 1 month follow up.12.   age of patient at graft: 74.3 yrs with myxoma, had implant failure and fracture through bone graft 42 months out, successfully treated with orif, wound break-down of posterior hip requiring debridement of bone wax, healed well after this at 60 months follow up.13.   age of patient at graft: 71.9 yrs with kcot, had submental fistula, hardware removal at 7 months follow up.14.   age of patient at graft: 64.5 yrs with mronj/osteomyelitis, had dehiscence at 6 months follow up.15.   age of patient at graft: 71.2 yrs with osteomyelitis, had cbct with bony destruction at right mandibular ramus, at medial aspect of mandibular resection at 24 months follow up.

• Brand Name: INFUSE BONE GRAFT
• 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: 18708987
• MDR Text Key: 335404701
• Report Number: 1030489-2024-00110
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• 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): Life Threatening; Required Intervention
• Patient Age: 51 YR