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

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

Patient Problem No Code Available (3191)

Event Date 09/09/2013

Event Type  Injury  

Event Description

It was reported in a publication that a retrospective review of patients with fracture non-unions included in two prospective databases was performed at two us level 1 trauma centers from (b)(6) 1998 (center 1) or (b)(6) 2004 (center 2), respectively, until (b)(6) 2010.A total of 182 patients (102 males and 80 females) met the inclusion criteria.The mean age was 44 ± 13.6 years.Sixty-eight patients were confirmed smokers, and 30 patients had a history of smoking and reported cessation prior to nonunion surgery.The remaining 84 patients reported to have never smoked.Patients were stratified into the following cohorts for analysis, based on the bone grafting modality: (1) autograft (n = 105), (2) allograft (n = 38), (3) allograft in combination with autograft (n = 16), and (4) rhbmp-2 with or without adjunctive bone grafting substitute (n = 23).The rhbmp-2 product was mixed with sterile saline and prepared immediately prior to use from a kit containing all necessary components, according to the manufacturer¿s instructions.In 6 patients, rhbmp-2 was administered without bone grafting adjunct, while in the remaining 17 patients rhbmp-2 was combined with allograft.The bmp2 cases consisted of 11 tibia, 5 femur, and 7 humerus surgeries.All patients were followed postoperatively for a minimum of 12 months, or until clinical and radiographic bone healing occurred.In the bmp2 cohort, 4 patients required revision bone grafting / non-union.

Manufacturer Narrative

Article citation: flierl et al.Outcomes and complication rates of different bone grafting modalities in long bone fracture nonunions: a retrospective cohort study in 182 patients.Journal of orthopaedic surgery and research 2013, 8:33.Patient: mean age 52 yrs (+/- 15).Patient: 7 males, 16 females.Implant date: between (b)(6) 1998 and (b)(6) 2010.(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.

Manufacturer Narrative

(b)(4).

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOIN
• 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: 4745573
• MDR Text Key: 5885645
• Report Number: 1030489-2015-00901
• Device Sequence Number: 1
• Product Code: MPW
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• 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
• Date Manufacturer Received: 04/08/2015
• 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): Required Intervention
• Patient Age: 00052 YR