MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCREW

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/10/2015

Event Type  Injury  

Event Description

Summary: the aim of this study was to determine the safety of recombinant human bone morphogenetic protein¿2 (rhbmp-2) use in posterior instrumented fusions in the pediatric population, focusing on cancer risk.In a previous study, the authors reported the short-term (mean follow-up of 11 months) safety and efficacy of rhbmp-2 in the pediatric age group.The present study reports their results with a minimum of 24 months¿ follow-up.During the premarket approval application for a higher dose of rhbmp-2 (40 mg) (amplify; medtronic sofamor danek), the risk of cancer was greater in the rhbmp-2 group compared with the control group.We retrospectively reviewed the charts of 57 consecutive pediatric patients who underwent posterior occipitocervical, cervical, thoracic, lumbar, or lumbosacral spine fusions with rhbmp-2 from (b)(6) 2007, to (b)(6) 2011, at (b)(6) hospital.Seven patients were excluded from the analysis because they were lost to follow-up and we were unable to obtain current information about them, and 3 patients died during the follow-up period, thus leaving 47 cases for our primary analysis.The 3 cases involving patients who died were analyzed separately the study group included 24 girls and 23 boys, and their age at surgery ranged from 0 years, 9 months to 20 years, 0 months, (mean age 11 years, 4 months).Increments of small (2.8 mg), medium (5.6 mg), and large (8.0 mg) kits of rhbmp-2 were used in each case and applied on a collagen sponge (infuse, medtronic sofamor danek).The rhbmp-2 was applied as described above along with some form of bone graft autograft, morselized cancellous bone allograft, and/or demineralized bone matrix (mastergraft matrix, medtronic sofamor danek).There were no cases of new cancers, degeneration, or metastasis of existing malignancies in our cohort of patients (95% ci 0%¿7.6%, wilson score interval).The mean duration of follow-up was 48.4 months across the range of doses of bmp administered (4.2¿36 mg, mean 14.4 mg).Three patients had preexisting tumors, including lipoblastomatosis (1 case), chordoma (1 case), and neurofibroma (1 case).Seven patients (12.3%) were lost to follow-up despite repeated attempts to contact them.Reported events: misplaced t-9 pedicle screw necessitating reoperation for revision.Reported product - unknown screw.

Manufacturer Narrative

D1, d4, g3: product identifiers are unknown.B3: date when the article was published.It is unknown if the reported screw is a medtronic product.This report is sent for notification purpose.Digital sharing of the article would be in violation of copyright permission christina sayama, md, mph, matthew willsey, bs, murali chintagumpala, md, alison brayton, rn, valentina briceño, rn, sheila l.Ryan, jd, mph, thomas g.Luerssen, md, steven w.Hwang, md, and andrew jea, md.Routine use of recombinant human bone morphogenetic protein¿2 in posterior fusions of the pediatric spine and incidence of cancer.J neurosurg pediatr, volume 16, july 2015.Doi: 10.3171/2014.10.Peds14199.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.

• Brand Name: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 16828939
• MDR Text Key: 314163756
• Report Number: 1030489-2023-00318
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 04/28/2023

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_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• 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: 04/28/2023
• 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