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 Problems Pain (1994); Disability (2371)

Event Date 09/22/2014

Event Type  Injury  

Event Description

It was reported that the patient was originally evaluated during childhood for difficulty walking, back pain, and urinary hesitancy.At that time, his defect was deemed ¿inoperable.¿ he presented again in adulthood with progressively worsening numbness in his legs and disturbance in his gait.He walked with a waddling gait, an exaggerated lumbar lordosis, and flexed hips.He had been unable to maintain employment and was on disability support.He was a multiple-pack-per-day smoker.He began to develop urinary incontinence.He reported difficulty sleeping and he could not lie flat.His physical examination showed some tenderness over a bony mass at the lower lumbar spine.He had some mild weakness in his left dorsiflexor and extensor hallucis longus muscles, but he had otherwise full strength in his legs.He did have pain on the straight leg raise test bilaterally.Imaging revealed a dysplastic l4¿5 vertebral body with some incorporation of the sacrum.He did not have a defined disc space between the presumed l-4 and l-5, but did have a space between the bony mass and sacrum.The patient underwent surgery using electromyography and neuronavigation.Screws were placed in l-2 and l-3 and the ilium for posterolateral fusion.The laminae and pedicles of the dysplastic l-5 hemivertebra were resected using a high-speed drill and rongeur.The wedge-shaped posterior deformity was resected.A filum section was not performed in this case.The posterolateral fusion material consisted of morsellized local bone, bone matrix, and rhbmp-2.The patient remained neurologically stable with mild left dorsiflexor weakness.He subjectively experienced improvement in his bowel and bladder symptoms.He had improvement in his ability to sit and could lie flat during sleeping.Ct scanning at 1 year after surgery showed completed posterolateral bony fusion with resection of the dorsal bony wedge.The anteroposterior diameter of the spinal canal at l5¿s1 was increased to 12.8 mm from 7.6 mm before surgery.While the patient reported that he improved, his survey scores 2 years after surgery showed severe disability.He reported an odi score of 60.He feels significantly impaired in his function due to physical and emotional health issues.He has significant pain and overall does not feel healthy.

Manufacturer Narrative

Literature article citation : ansari et al.¿dorsal midline hemivertebra at the lumbosacral junction: report of 2 cases¿.J neurosurg spine.2014 oct 24:1-6.(b)(6).(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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: 4290275
• MDR Text Key: 5054573
• Report Number: 1030489-2014-04605
• 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: Physician
• Type of Report: Initial
• Report Date: 11/06/2014

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: 11/06/2014
• Initial Date FDA Received: 12/02/2014
• 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: 00031 YR