MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Literature citation: christine baldus, rn mhs, michael p.Kelly, md, elizabeth l.Yanik, phd, scm , bettina f.Drake, phd mph, azeem ahmad, bs, addisumesfin, md, keith bridwell, md; ¿incidence of cancer in spinal deformity patients receiving high-dose (=40mg) bone morphogenetic protein (rhbmp-2/acs)¿ average age at time of first exposure: 52.8 years 138 males and 455 females.(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that a study was carried out to determine if there is an increased risk of developing cancer after exposure to high-dose recombinant human bone morphogenetic protein-2 (rhbmp-2) and if risk is dose and/or exposure-dependent.642 adult deformity patients from a single institution receiving a cumulative rhbmp-2 dose=40mg from 7/2002-7/2009 were identified.Forty-nine patients were lost-to-follow-up.Thus, data for 593 adult deformity patients from a single institution receiving a cumulative rhbmp-2 dose =40mg from 7/2002-7/2009 was available for analysis.Mean cumulative rhbmp-2 dose was 113.5mg with 85% having one exposure (range: 1-8).To determine the occurrence of a cancer event, questionnaires were mailed and telephone follow-up attempted for non-responders.Only cancers tracked by the national cancer institute (nci) seer registry were included.Observed cancer counts were compared to expected cancer counts based on general population incidence rates within 5-year age strata.Cumulative incidence competing risk (cicr) was used to evaluate the association between rhbmp-2 exposure and cancer controlling for potential confounding variables.There were 20 deaths identified: 3 were related to cancer, 2 were possibly/probably related, 14 were unrelated and 1 was of unknown relationship.Our total 8-year cumulative incidence of new seer cancer accounting for the competing risk of death was 7.4% for 30 cancers/ in 593 patients.Fewer cancers were observed than expected based on general population rates, though the difference was not statistically significant.Cicr found neither cumulative rhbmp-2 dose nor number of exposures increased the risk of developing a post-exposure cancer after controlling for known cancer risk factors.The incidence of a seer cancer after rhbmp-2 exposure was similar to incidence reported by the nci.There were no significant rhbmp-2 dose or multi-exposure related risks of developing a life-threatening cancer.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6776199
• MDR Text Key: 82108819
• Report Number: 1030489-2017-01875
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 53 YR