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 Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Stenosis (2263); Post Operative Wound Infection (2446)

Event Date 04/12/2010

Event Type  Injury  

Event Description

Summary: a retrospective review of 19 consecutive pediatric patients who underwent posterior occiptocervical, cervical, thoracic, lumbar, or lumbosacral spine fusion from (b)(6) 2007, to (b)(6) 2008, at (b)(6) hospital was performed.The average age was approximately 12 years old (range, 9 months to 20 years).The minimum follow-up was 17 months (average of 19 months, range: 17¿25 months), with computed tomography (ct) evaluation and grading of fusion by an independent radiologist at 3 months after surgery.Procedure performed the amount of rhbmp-2 applied ranged from 1 small kit (4.2 mg) to 3 large kits (36.0 mg) on a collagen sponge.The rhbmp-2 was applied as described, along with some form of bone graft or a compression-resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier most commonly, the rhbmp-2 was applied with local autograft and allograft (6 of 19 patients).In 5 patients, the rhbmp-2 was used with allograft alone while in four patients it was used with local autograft alone.Two patients had allograft along with iliac crest autograft.In 2 patients, local autograft was applied along with a compression-resistant matrix.For 1 patient, we applied rhbmp-2 with a compression resistant matrix alone.Reported event: one patient had bony overgrowth with symptoms of spinal cord compression (symptomatic canal re-stenosis) that necessitated a return to the operating room for decompression at 3 months postoperatively along with superficial wound infection.Postoperative ct scan showed decompression of the spinal canal.Patient's neurological status steadily improved; however, she again slowly deteriorated at approximately 3 months after surgery.Ct scan at 3 months postoperatively showed bony regrowth at the site of decompression and restenosis of the spinal canal.Patient underwent a repeat posterior decompression and was noted to have substantial bony overgrowth into the spinal canal intraoperatively.No bmp was used at the time of the second decompression.The patient once again improved neurologically over the ensuing months.Medtronic infuse was reported in the literature.See attached article.

Manufacturer Narrative

Daniel k.Fahim, william e.Whitehead, daniel j.Curry, robert c.Dauser, thomas g.Luerssen, andrew jea routine use of recombinant human bone morphogenetic protein-2 in posterior fusions of the pediatric spine: safety profile and efficacy in the early postoperative period neurosurgery 67:1195¿1204, 2010 doi: 10.1227/neu.0b013e3181f258ba d4: product identifiers are unknown h6: 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.

• 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: 16866791
• MDR Text Key: 314527753
• Report Number: 1030489-2023-00332
• 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: 05/04/2023

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 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
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/04/2023
• 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): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female