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

Catalog Number 7510800

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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 on: (b)(6) 2008: the patient was pre-operatively diagnosed with low back pain, lumbar radiculopathy and underwent following procedures: l3 far decompressive laminectomy, bilateral medial facetectomy, foraminotomy completely decompressing the thecal sac, nerve root.L4 far decompressive laminectomy, bilateral medial facetectomy, foraminotomy completely decompressing the thecal sac, nerve root.Redo right and left l5,l6 laminectomy, medial, facetectomy and foraminotomy.Posterior lumbar interbody fusion l3-l4, l4-l5, l5-l6.Posterolateral arthrodesis l3-l4, l4-l5, l5-l6.Placement of interbody integrated spine prosthetic device l3-4, l4-5, l5-6.Pedicle screw fixation using spiral 90-d, l3, l4, l5 and l6.Placement of autograft morselized bone harvesting with bone morphogenic protein and genex for posterolateral arthrodesis l3-l4, l5-l6.Use of ebi bone stimulator.As per op-notes, ¿discectomy was performed.After that was completed, cages were placed.The interbody arthrodesis was completed with bone morphogenic protein and autograft.After that the technique of identifying the process, drill, gearshift tap 7.7 x 50 mm screws were placed bilaterally at l3, l4, l5 and l6.After that was done, two 110 mm rods were contoured into place.Three crossbars connectors were torqued to the appropriate levels well as the screws.¿ (b)(6) 2008: the patient was preoperatively diagnosed with low back pain, status lumbar fusion l2-l6 and underwent removal of external bone stimulator.(b)(6) 2010: the patient was preoperatively diagnosed with infected intrathecal pump and infected posterior lumbar and underwent following procedures removal of intrathecal pump.Simple incision and drainage of posterior lumbar wound.On (b)(6) 2010: the patient was discharged from the hospital.Discharge diagnosis: status post postsurgical lumbar wound with cerebrospinal fluid leak, possible meningitis.Chronic low back pain, currently stable.21w.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 6593267
• MDR Text Key: 76023887
• Report Number: 1030489-2017-01323
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• 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: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

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
• Device Expiration Date: 10/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110606AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 05/01/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2007
• 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: 56 YR