MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number MSB_UNK_INDUCTOS

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Burning Sensation (2146); Neck Pain (2433)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from healthcare provider via manufacturer representative regarding an event happened during post op of the reported product.It was reported that, the patient suffered a left and right sided pain radiating along what might have been the l5 segment, reaching the calf as well as the outer aspect of the feet.An mri demonstrated disc bulging of the l4/5 disc, potentially explaining his pain.At this time, patient had no low back pain and had never had in the past.A transforaminal injection of 8 mg of dexamethasone was done by the transforaminal route at the level l4/5 without any improvement of his pain.It has to be noted that this injection covered the l4 nerve root and not the nerve root (l5) that potentially produced his symptoms.It was subsequently decided to treat the patient with an injection of discogel, an ¿implant¿, into the l4/5 disc.According to the patient, no low back pain or radiation into the lower extremities was felt, indicating the l4/5 disc was not the origin of his radiating pain.0.8 ml of discogel were subsequently injected.Immediately after this treatment, patient developed low back pain in a bar across the low back associated with pain radiating into the two buttocks and posterior aspect of his two thighs that he had never felt prior to the intervention.This pain prevented him from walking normally.In (b)(6) 2021, patient consulted for his low back and left sided leg pain and he was informed that the only therapeutic option based on his clinical history, clinical examination and the mri was a discectomy l4/5 with the disc being replaced with a cage.Patient accepted to undergo the intervention, done on (b)(6) 2021 via an anterior approach with implantation of a stand-alone alif cage in which 12 mg of induktos was introduced into the cage.The induktos dose recommended by the manufacturer is 4 mg for a one level intervention.Physician communication with the product manager at medtronic (b)(4) clearly indicates that 12 mg cannot be contained in the cage and therefore most probably must have partially ended up in the spinal canal.After the operation, the patient¿s previous pains had not changed, indicating the disc that had been removed was not the nociceptor.In addition, patient rapidly developed new pains in the form of burning sensations over the sacrum, under his two feet, into the scrotum with a predominance for the left side as well as up towards the neck and head.No motor dysfunction was observed.In (b)(6) 2022, patient had two injections of steroids into the spinal canal with a moderate clinical improvement.Thereafter he consulted with an orthopedic surgeon in the region, not usually practicing spine surgery, who sent him for radiological examinations, among which a spect-ct demonstrated a non union.On this examination it was also observed that one of the screws (l5 left) penetrated the posterior wall of the vertebra, projecting over the corresponding nerve root.This provided an indication for another surgical intervention by the orthopedic surgeon, made via a laparotomy in the presence of a spine surgeon and an abdominal surgeon.The patient was re-operated and the screw was changed.The first week after this intervention, the patient experienced some improvement, eventually due to the postoperative analgesic therapy, but after this period, his previous pain became stronger, in particular the one radiating into the scrotum on the left side.No modification of his original left sided leg pain or other pains potentially provoked by a conflict between the screw and the l5 nerve root was observed.In april, it was decided that patient should undergo pharmacological testing to better understand the mechanism for his different pains.Firstly, it was made an intravenous infusion of lidoc aine, a test strongly specific for neuropathic pain if positive.The outcome of this test was uncertain since we never managed to arrive at the plasma concentration needed for the test to be valid and this due to rapid metabolism of the compound.The patient thereafter was subjected to an intrathecal injection of fentanyl at a dose of 75 ug.The injection was done at the t12/l1 interspace and rapidly produced profound analgesia with almost complete disappearance of all pain, lasting for about one hour, a duration that is not unusual to observe with a single injection done with barbotage.The patient has thereafter been treated with fentanyl patches (durogesic) in a dose increasing progressively to 100 ug/24h that has reduced his pain by up to one half at best.It has also permitted him to regain sleep that has now been completely restored.When waking up in the morning his pain is now absent but returns as soon as gets up and around.A pharmacological trial with pregabalin followed by mexelitene has as of today not produced a significant reduction of his burning pain components.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14876313
• MDR Text Key: 295056804
• Report Number: 1030489-2022-00597
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_INDUCTOS
• Device Catalogue Number: MSB_UNK_INDUCTOS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2022
• 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 Age: 60 YR
• Patient Sex: Male