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 Unspecified Infection (1930); Pain (1994); Osteolysis (2377); Impaired Healing (2378)

Event Date 09/22/2023

Event Type  Injury  

Event Description

Summary: 16 patients in the study group were implanted with calcium phosphate combined with recombinant human bone morphogenetic pro tein-2/autologous bone particles.Findings indicate that the effect of calcium phosphate combined with recombinant human bone morphogenetic protein-2 during the second stage operation of the masquelet membrane induction technique in the treatment of tibial infectious bone defect is good and safe.Reported events: 1.Six months after the second stage operation, peripheral blood inflammatory indexes such as white blood cell count, c-reactive protein, and erythrocyte sedimentation rate were detected.Imaging bone healing time, bone healing x-ray score, bone defect healing classification, and adjacent joint function were recorded.2.1 case of infection recurrence in the study group.Re-debridement, bone grafting, and after fixation, infection was controlled and function was restored.3.There were 2 cases of nail tract infection in the study group.After careful cleaning of the nail tract, the infection was cured with symptomatic treatment.4.There was 1 case in the study group who experienced bone absorption and delayed healing after bone grafting, and the bone healed after re-grafting.5.There were 2 cases of pain in the iliac bone removal area in the study group, which were relieved after analgesic treatment.6.One case in the study group developed infection in the iliac bone harvesting area, which was cured after redebridement.7.White blood cell count, erythrocyte sedimentation rate, and c-reactive protein levels of the two groups 6 months after the second stage operation were significantly lower than those before the first stage operation.There was no significant difference in each index between the two groups.Bone healing time in the study group was shorter than that in the control group.The samantha x-ray score of the study group 6 months after the second stage operation was higher than that of the control group.The excellent and good rate of bone defect healing and adjacent joint function of the study group was higher than that of the control group.There was no significant difference in the recurrence rate and complication rate between the two groups.

Manufacturer Narrative

B3: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: msb_unk_bmp2_acs, lot#: unknown, ubd: unknown, udi#: unknown product id: msb_unk_bmp2_acs, lot#: unknown, ubd: unknown, udi#: unknown product id: msb_unk_bmp2_acs, lot#: unknown, ubd: unknown, udi#: unknown product id: msb_unk_bmp2_acs, lot#: unknown, ubd: unknown, udi#: unknown xufeng, j., miao, l., guangping, h., qing, z., zhaoyao, z., yuxin, q., peng, t., ping, l., yuchi, c.Calcium phosphate combined with recombinant human bone morphogenetic protein-2 in repair and reconstruction of tibial infectious bone defects.Chinese journal of t issue engineering research 2024 28:17 (2625-2630).Doi:10.12307/2024.475.Digital sharing of the article would be in violation of copyright permission.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 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: 18824356
• MDR Text Key: 336733660
• Report Number: 1030489-2024-00145
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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: 02/15/2024
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention