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

Catalog Number UNKNOWN

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

Event Date 09/10/2014

Event Type  Injury  

Event Description

Pt demographics: 146 males and 495 females with mean age at 1st exposure of 53.4±14.3.Sixty percent (386) had past smoking history.Forty-nine patients (7.6%) had a seer ca prior to bmp exposure.It was reported by baldus et al in a poster presentation (prevalence of cancer in spinal deformity patients receiving high dose (= 40mg) bone morphogenetic protein (rhbmp-2).Final program of the 49th annual meeting <(>&<)> course of the scoliosis research society (srs), 10- to 13-sept- 2014) that adult deformity patients from a single institution receiving a cumulative bmp dose = 40mg from 7/2002 to 7/2009 were identified.To determine the occurrence of a primary ca or recurrent/metastasis, questionnaires were mailed and telephone follow-up attempted for all non-responders.Of 690 patients identified, 49 patients were excluded (16 refused, 28 non-responders, 5 deceased with unknown ca histories), leaving 641 (93%) available for analysis.The cumulative bmp dose was 114mg±76 with most patients (539, 84%) having 1 exposure (mean 1.2±0.54, range 1-8).The 34 patients (5%) had a seer ca after exposure and 6 (1%) had a recurrence/metastasis.Patients were classified by cumulative bmp dose: medium (40-89mg, n=327) or high (= 90mg, n=314).Cancer rate was higher in the medium vs high dose, but this was not statistically significant (medium dose: 23/327, 7% vs high dose: 11/314, 4%; p=0.053).Recurrence/ metastasis was the same in both groups (3 each group, p=1.000).Binary logistic analysis showed cumulative bmp dose (p=0.13, or=1.00, ci: 0.30-1.37) and number of exposures (p=0.17, or=1.49, ci: 0.86-2.68) did not increase the risk of developing a new seer ca even after controlling for risk factors known to affect development of seer ca (age, gender, race, smoking status, ca history, region of residence).Prevalence rate in our patient population (5.3%) was less than expected based on seer crude age-adjusted prevalence rates (7.1%).The gender-adjusted nci/seer rate for patients 50-59 years is 4.24%.Exposure to high dose rhbmp-2 did not increase the risk of development of a new or recurrent seer ca.Prevalence of new post-bmp seer ca was not higher than reported by (b)(4).The 34 patients had a seer cancer after exposure to bmp2.

Manufacturer Narrative

(b)(4).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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4266642
• MDR Text Key: 5293728
• Report Number: 1030489-2014-04475
• 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: Literature
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• 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: 00053 YR