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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

A2: please note that the age is based off average age of patient involved in this event a3: please note that the gender is based off as per the majority of patients.B3.Please note that this date is based off of the date of publication of article as the event dates were not provided in the published article.D4: product identifiers are unknown.D section 6a: implant date 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.Digital sharing of the article would be in violation of copyright permission ravinder raj bains, kathryn e.Royse, jacob fennessy, elizabeth p.Norheim, ehsan tabaraee, jessica e.Harris, calvin c.Kuo and kern h.Guppy."are there differences in the reoperation rates for operative adjacent-segment disease between alif+ps, plif+ps, tlif+ps, and llif+ps? an analysis of a cohort of 5291 patients." j neurosurg spine.Https://thejns.Org/doi/abs/10.3171/2023.12.Spine231251.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Summary: biomechanical factors in lumbar fusions accelerate the development of adjacent-segment disease (asd).Stiffness in the fused segment increases motion in the adjacent levels, resulting in asd.The objective of this study was to determine if there are differences in the reoperation rates for symptomatic asd (operative asd) between anterior lumbar interbody fusion plus pedicle screws (alif+ps), posterior lumbar interbody fusion plus pedicle screws (plif+ps), transforaminal lumbar interbody fusion plus pedicle screws (tlif+ps), and lateral lumbar interbody fusion plus pedicle screws (llif+ps).Reported events: a retrospective study using data from the kaiser permanente spine registry identified an adult cohort (= 18 years old) with degenerative disc disease who underwent primary lumbar interbody fusions with pedicle screws between l3 to s1.The objective of this study was to compare the incidence rates of operative asd and the associated risks of asd among these common interbody fusion techniques with posterior pedicle screws (ps) (alif+ps vs plif+ps vs tlif+ps vs llif+ps) for primary lumbar fusions between l3 and s1 in a cohort of patients with degenerative disc disease.The primary outcome of interest in this study was the reoperation rate due to symptomatic asd (operative asd).The cohort of adult patients who underwent primary lumbar fusions with interbody fusion devices and pedicle screws between l3 and s1 for degenerative disc disease consisted of 5291 patients with 23.3% having undergone alif+ps (n = 1231), 21.1% plif+ps (n = 1116), 53.0% tlif (n = 2804), and 2.6% llif+ps (n =140).The anterior and lateral approaches had the highest percentages of bmp usage during fusions (83.6% of alif+ps patients received bmp compared with 88.6% of llif+ps patients, 44.4% of plif+ps patients, and 58.1% of tlif+ps patients).Bmp was used in total of 3278 patients (62.0 %) where consists of alif+ps, plif+ps, tlif+ps, llif+ps as 1029, 496, 1629 and 124 patients respectively.Admitting diagnosis at facility were spondylolisthesis, degenerative disc disease.There was a total of 443 cases of operative asd, with an overall incidence rate of 8.37%.The 1-, 2-, and 5-year cumulative incidence estimates of reoperation due to asd were 0.89%, 4.27%, and 7.22% respectively.Conclusion: study presented data on over 5000 patients with more than 6 years of follow-up and found no differences in the reoperation rates for symptomatic asd (operative asd) between alif+ps and plif+ps, tlif+ps, or llif+ps.

• 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: 19164967
• MDR Text Key: 340841248
• Report Number: 1030489-2024-00318
• 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: 04/23/2024

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?: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/23/2024
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White