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

Catalog Number 7510200

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

Patient Problems Dysphagia/ Odynophagia (1815); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Respiratory Distress (2045); Weakness (2145); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterior lumbar interbody fusion using rhbmp-2/acs.It was reported that 4 months later, the patient underwent a plif revision surgery using rhbmp-2/acs.The patient's post-operative period was marked by severe pain.Following the surgery, the patient suffered from autonomic neuropathy, small fiber neuropathy, peripheral neuropathy, muscle atrophy and nerve damage, inflammatory reactions, chronic radiculitis, retrograde ejaculation, sterility, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, dysphagia, difficulty breathing, difficulty gripping and holding items, and chronic pain.The patient now suffers from bone overgrowth causing nerve compression, chronic pain and radiculitis, and emotional distress and mental anguish.

Manufacturer Narrative

(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.

Event Description

It was reported that on (b)(6) 2009 the patient underwent a posterior lumbar interbody fusion surgery at l4-5, l5-s1 using bmp2_acs.It was reported that on (b)(6) 2009 the patient underwent a plif revision surgery at l4-5, l5-s1 using bmp2_acs.The patient's post-operative period was marked by nerve damage and chronic pain in limbs.

Event Description

It was reported that on (b)(6) 2009: the patient presented with disk degenerative changes at l5-s1 level.Disk herniation with foraminal stenosis, left more than right, at l5-s1 level.Disk degenerative changes and foraminal stenosis at l4-5.The patient underwent bilateral l4, l2 and s2 laminectomies.Bilateral foraminotomies and nerve root decompression at l4, l5 and s1, l4-5 and l5-s1 diskectomy.Inter-body fusion l4-5 and l5-s1 level.Posterior instrumentation (pedicle screw fixation) l4-l5-s1.Postero-lateral fusion with auto-graft bone and bmp , l4-l5-s1.Insertion of epidural "jp" drain.The system was used from globus.C-arm fluoroscopy.As per op notes, ".Bilateral laminectomy was done at l4, l5 and s1.Partial laminectomy was done at l4.Bilateral foraminotomy was done at l4, l5 and s1.Pedicle screws were placed first on the left and then on the right side.Laminectomy and discectomy was performed at l4-l5 and instrumentation from l4 to s1.The epidural vein was coagulated at l5-s1.The disk space was measured and an 8 mm by 26 mm inter-body cage was used.Bmp was placed inside the cage.Similar steps were executed at the l4-5 level.The auto-graft wound that was collected from the laminectomy site with the rest of the bmp that was left was placed bilaterally over the transverse process of l4, l5 and s1 (360 degree fusion), then the retractor was removed.".The patient tolerated the procedure well.

Manufacturer Narrative

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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3668064
• MDR Text Key: 4320299
• Report Number: 1030489-2014-00688
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110707AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2008
• 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