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

Catalog Number 7510600

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

Patient Problems Ossification (1428); Dysphagia/ Odynophagia (1815); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Respiratory Distress (2045); Weakness (2145); Discharge (2225); Osteolysis (2377); Ambulation Difficulties (2544); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent a lumbar interbody fusion 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, 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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent an alif/xilf fusion surgery at l4-5 using rhbmp2 and an interbody cage.The patient's post-operative period was marked by urinary complications, infections, odor/discharge, painful intercourse, and difficulty walking.

Event Description

It was reported that on (b)(6) 2007: the patient presented with degenerative disc disease to level l5-s1 and l4-5.Low back pain.Lower extremity sciatica.Lumbar spondylosis to level l4-5, l5-s1.The patient underwent the following procedures: anterior lumbar discectomy infusion/arthrodesis through a retroperitoneal extreme lateral or xlif procedure or approach at l4-5.Anterior instrumentation at l4-5.Inter-body spacer block or cage at l4-5.Posterior fusion, l4-5 with posterior non-segmental instrumentation, l4-5.Anterior lumbar discectomy and fusion second level, l5-s1 through a retroperitoneal trans-s1 approach.Anterior instrumentation at l5-s1.Inter-body cage at l5-s1.Bone grafting with bone morphogenic protein (bmp).The lordotic cage, 10x45 mm at l4-5.Four screws (6.5 mm), 240s and 245s at l4 and l5 pedicles with the appropriate rods.Bmp was used in the cages.The trans-s1 bolt or rod was used for fixation at l5-s1.It was a 40 mm bolt.Again, bmp was used along with the local auto-graft bone at the l4-5 level.Intra-operative neural monitoring by using surgeon driven monitoring.As per-op notes, "the l4-5 disk space was identified and annulotomy was performed.The disc was removed.The cage was prepared, packed with the bmp and then the trial was removed and the final cage was impacted into place.Excellent placement was confirmed with anterior-posterior and lateral c-arm.At s1, complete discectomy was performed utilizing the trans-s1 disc removal set.The disc space was packed with the local autogenous bone along with bmp (bone morphogenic protein) and some bone graft.".

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: 3659420
• MDR Text Key: 4313299
• Report Number: 1030489-2014-00721
• 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: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2009
• Device Catalogue Number: 7510600
• Device Lot Number: M110601AAA
• 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: 10/28/2006
• 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