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 Pain (1994); Tingling (2171); Stenosis (2263); Dysuria (2684)

Event Type  Injury  

Event Description

Manufacturer Narrative

(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.

Manufacturer Narrative

Review of radiographic images found as follows: on (b)(6) 2008 lumbar mri sagittal t2 views show some desiccation at l4 and l5.There is disc narrowing at l5 and bulging of the annulus at both levels.Conus is seen at l1/2.Lumbar lordosis is normal.No stenosis is seen.Axial views do show annular tear ventral to the left l5 root foramen.Root distribution within the dural sac is normal.Small facet cyst is seen on the right at l4/5.On (b)(6) 2008 cervical mri sagittal t2 image sows reversal of the cervical lordosis.No stenosis or cord signal changes are noted.Axial views also show no signs of cord compression.Quality of study is poor.On (b)(6) 2008 discogram no images provided (b)(6) 2008 post discogram lumbar ct shows annular tears bilaterally at l5 with movement of contrast to the periphery of the disc bilaterally.No frank extradural contrast is seen.At l4 there is also movement of contrast posteriorly to the right without dye in the extradural space.L3 disc appears normal with central concentration of dye.Provocative pain reporting is not documented diminishing diagnostic value of this study.On (b)(6) 2009 thoracic myelogram lumbar lateral view shows pedicle screw fixation from l4 to s1 with peek spacers within the l4 and l5 discs.Ap views show the spacers eccentric to the left.Myelogram shows no cord compression although there are several bulging discs that attenuate the ventral subarachnoid space.This is most pronounced at t7/8.On (b)(6) 2009 thoracic ct post myelography right eccentric disc bulge is noted at t7/8 that does not touch the cord, but does narrow the ventral subarachnoid space about 75%.On (b)(6) 2009 lumbar myelogram multiple plane films are taken with contrast within the subarachnoid space.There is a slight bulge of the l3/4 disc which is more pronounced in extension.No root cut off is seen at any level.On (b)(6) 2009 postmyelogram lumbar ct dye column is concentric without signs of external compression.Screws are well positioned.Spacer are eccentric to the right at both l4 and l5.Posterior contruct extends from l4-l5-s1.On (b)(6) 2010 pelvic us no spinal pathology elucidated (b)(6) 2010 lumbar spine series construct remains from l4 to s1.Spacers are well seen within the l4 and l5 discs however very little fusion bone is seen.On (b)(6) 2011 myelogram lumbar when compared to the myelogram of (b)(6) 2009 shows subtle worsening of the disc bulge and stenosis at l3.This is still mostly resolved in flexion views.On (b)(6) 2011 postmyelogram lumbar ct concentric stenosis is seen at l3/4 due partly to facet hypertrophy but also to disc bulging.Stenosis is moderate at most.Implant alignment remains excellent.

• 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: 3927484
• MDR Text Key: 4667379
• Report Number: 1030489-2014-03202
• 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: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/19/2014

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
• Device Expiration Date: 11/01/2010
• Device Catalogue Number: 7510800
• Device Lot Number: M110710AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2014
• 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): Required Intervention
• Patient Weight: 91