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 Muscle Spasm(s) (1966); Loss of Range of Motion (2032); Weakness (2145); Inadequate Pain Relief (2388)

Event Type  Injury  

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) 2010 the patient was presented for office visit for evaluation of patient with back pain and preoperative risk assessment.(b)(6) 2010 the patient underwent l5-s1 anterior posterior spinal fusion.Partial vertebral corpectomy, s1 with decompressions of cauda equinna and exiting nerve roots.Implantation of structural allograft.Anterior internal fixation.Preoperative diagnosis: lumbar disc disease.Low back pain.Discogenic pain.Bilateral referred leg pain.Perop notes: after opening the anterior rectus fascia using the knife blade, muscle-splitting technique was then used.Preperitoneal approach was obtained maintaining exposure for exposing the l5-s1 disk space clearly identifying the iliac artery and vein on the left side, as well as the left ureter.These remained out of the field of dissection.Disk material was removed from the l5-si disk space and then placed in the prosthesis and the bone fragments, and proceeded with the fusion.He will dictate this portion of the operation, as well as placing 1 screw to hold it in place.At the conclusion of this procedure, there was no evidence of any bleeding.The wound was then irrigated.A partial vertebral carpectomy was carried out at l5-sl of the s1 vertebral body to fully remove all the fibrocartilaginous debris posteriorly that as the bone graft was impacted, that iatrogenic cauda equina compression would not occur.The majority of the disk was removed using a combination of knife and ring curettes.Then, the fibrocartilaginous debris and endplate were removed, the partial vertebral carpectomy of s1 by using curets to remove a portion vertebral body and then reflecting material upwards away from the pll, thus decompressing the cauda equina and exiting nerve roots, once the decompression was judged to be satisfactory, then attention was turned to the fusion.Anterior lumbar interbody fusion at l5-sl was carried out by fashioning parallel bleeding bony surfaces at the l5-sl interspace using a ring curette.An appropriate size allograft spacer was selected, filled with infuse sponge and then impacted under compression into the interspace.Anterior internal fixation was carried out by selecting appropriate sized screw and screwing into the s1 vertebral body internally fixing the bone and bone graft.This was a 6.5 mm titanium synthes screw.The wound was inspected.Thorough irrigation was carried out.(b)(6) 2010 the patient was presented for office visit for evaluation.Assessments: lumbar syndrome.Lumbosacral degeneration.(b)(6) 2010 the patient was presented for office visit with back, leg pain, numbness, constipation.Musculoskeletal examinations: he has pain in his low back while performing a straight leg raise test on the left and the right.He has good symmetrical deep tendon reflexes and the most exquisite pain while loading the facet joints.(b)(6) 2010 the patient underwent mri of the lumbar spine.Impressions: there has been interval performance of anterior interbody fusion at l5-s1.The disc prosthesis is in place.There are right-sided pedicle screws with a posterior fixation rod and l5 and s1.(b)(6) 2011 the patient underwent mri of the lumbar spine.Impressions: no complication was reported.(b)(6) 2013 the patient was presented for office visit with lbp, right-sided sacroiliac pain and left-sided radicular component.Impressions: lumbar spondylosis.(b)(6) 2013 the patient underwent ct scan of the lumbar spine.Impressions: l5-s1 uncomplicated appearing anterior and posterior fusions.Shore.Pedicles an spondylosis with canal and neural foraminal narrowing, as described above.Most prominent findings are at l4-l5.The patient also underwent xrays of the lumbar spine.Impressions: postoperative changes an spondylosis, limited range of motion but no evidence of instability noted.(b)(6) 2013 the patient was presented for office visit with low back pain and right le pain.Impressions: lumbar spondylosis.(b)(6) 2013 the patient was presented for office visit with coccydynia.This pain is worse whenever he sits down, and he has required the use of an inner tube.(b)(6) 2013 the patient underwent.Coccygeal injection.Fluoroscopic localization.Preoperative diagnosis: coccydynia, lumbar spondylosis.(b)(6) 2013 the patient was presented for office visit for follow up.Patient reported the leg pain radiates from the low back into the gluteal area down the posterior lower extremity into the leg and into the dorsal aspect of the foot.The complaint is made worse with extension of the leg as well with straining and coughing.The pain is quite sharp and severe and is also associated with the sensation of numbness and weakness.There is no paralysis or new loss of bowel and bladder function.The pain gets worse with any sort of physical activity.In particular bending twisting or lifting causes severe pain in the lumbar area associated with spasm.The patient's back pain is bad enough that it interferes with the patient's ability to function with activities of daily living.The pain is clearly relieved by rest.There is no associated complaint of lever sweats and chills recent or distant history of weight loss or malignancy.There is no history of recent major trauma.There is no paralysis or incontinence.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5182890
• MDR Text Key: 29791129
• Report Number: 1030489-2015-02843
• 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
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2012
• Device Catalogue Number: 7510600
• Device Lot Number: M110811AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2010
• 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 Weight: 108