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 Dysphagia/ Odynophagia (1815); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Respiratory Distress (2045); Weakness (2145); Osteolysis (2377); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterior lumbar interbody fusion, and on (b)(6) 2005 the patient underwent a posterior cervical discectomy and fusion, both times using rhbmp-2/acs with a metal cage.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, 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 severe injuries and damages, including bone overgrowth causing nerve compression, chronic pain and radiculitis.

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) 2005: patient who has undergone previous instrumented fusion l5-s1.Admitting diagnosis: degenerative disk disease, lumbar spondylosis.Pre operative diagnosis: rule out adjacent facet disease, rule out painful hardware, rule out pseudoarthrosis,l5-s1.Procedure: posterior lumbar lateral interfacet fusion with rhbmp-2, allograft, autograft and prp matrix, l4-5.Posterior lumbar hemilaminotomy, left and right l5-s1.Segmental pedicle screw fixation, l4-5.Removal of segmental pedicle screw fixation, l5-s1 with exploration of fusion and biopsy of fusion mass, l5-s1.Scar revision 5 cm.Somatosensory evoked potential, direct pedicle screw stimulation technique.Findings: complete and solid fusion to the pedicle screw sites.There was no evidence of any collapse or pseudoarthrosis deficits at the l5-s1 level.Biopsy revealed a very hefty bleeding trabecular bone pattern indicative of a very viable bone posterolaterally.At l4-5, significant facet cyst was noted along with degenerative changes of the facet complex, these were considered to be primary cause of low back pain.There was no tissue reaction to the instrumentation and no evidence of any loosening.Per operative report: ".Fusion was extended to l4-5.Using midas-rex system, the cortical surface of the lamina as well as facet complex was decorticated to bleeding trabecular bone along with the lateral part of the pars and the medial transverse process avoiding extensive dissection posterolaterally.Next, the rhbmp-2 was placed in the facet space identified on both sides, packed with bone graft.A rolled bmp sponge was then placed on the interlaminar surfaces of l5 and l4.Bone graft was then placed.Allograft, autograft and prp matrix was re-harvested.Patient tolerated the procedure well.The patient was awakened, extubated moving all extremities spontaneously at the end of procedure.No complications were noted.".

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: 3654053
• MDR Text Key: 4284308
• Report Number: 1030489-2014-00654
• 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
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510600
• Device Lot Number: M114005AAM
• 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
• 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: 44 YR