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 Post Operative Wound Infection (2446)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported in a publication that the authors undertook a prospective study of consecutive patients between 2009 and 2012.Patients underwent alif performed by a single spine surgeon and a single vascular surgeon.Indications for surgery were severe discogenic pain, radiculopathy, and grade 1 and 2 degenerative and isthmic spondylolisthesis.All patients received a single separate impacted peek cage filled with rhbmp-2/acs per level.The rhbmp-2 was prepared at a fixed concentration of 1.5 mg/ml, with the sponge trimmed to the required cage volume.No rhbmp-2 was placed outside the cage.An anterior titanium buttress plate fixed the cage using a multiawl technique performed free hand for self-tapping screw placement.The anterior plate was triangular with 3 bone screws at l5¿s1 and rectangular with 4 screws at l4¿5.A layer of surgicel (b)(4) was then placed over the alif construct.A hybrid construct comprised an a-mav artificial disc replacement at l4¿5 combined with an alif at l5¿s1.The artificial disc replacement was performed at l4¿5 for l4¿5 discogenic pain without facet arthropathy; however, if facet arthropathy was present, an l4¿5 alif was undertaken.The cohort consisted of 131 patients with a median patient follow-up of 12 months (range 6¿24 months).There was no significant difference between the number of complications experienced by the alif or hybrid patients.The overall fusion rate (alif and hybrid patients) confirmed on hd ct coronal and sagittal views improved from 76.3% at 6 months, to 92.4% at 9 months, and to 96.9% at 12 months.The overall complication rate was 19.1% four patients had a superficial wound infection (3 after lower midline incisions for hybrid procedures and 1 after a transverse incision for an l5¿s1 alif).Wound cultures from these 4 patients grew staphylococci species, and all infections were successfully treated with oral antibiotics (flucloxacillin and clindamycin).No deep wound infections occurred.

Manufacturer Narrative

Article citation: malham et al.Anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2: a prospective study of complications.J neurosurg: spine / october 3, 2014 (doi: 10.3171/2014.8.Spine13524).Mean age of 45.3 years (range 23¿70 years).67 males, 64 females.Therapy date: 2009-2012.(b)(6).(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: 4227019
• MDR Text Key: 15810700
• Report Number: 1030489-2014-04217
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000058
• 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
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• 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: 10/07/2014
• 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
• Treatment: PEEK CAGE, ANTERIOR PLATE
• Patient Outcome(s): Required Intervention
• Patient Age: 00045 YR