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 Tingling (2171); Numbness (2415); Sleep Dysfunction (2517)

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.

Event Description

It was reported that (b)(6) 2008: the patient underwent x-ray of chest, two views.Impression: no acute infiltrates.The patient also underwent ecg and lab tests.On (b)(6) 2008: the patient presented for pre-op physical examination.Musculoskeletal exam showed tenderness on palpation of l5-s1 spine.On (b)(6) 2008: the patient presented for an office visit with diagnosis of two level degenerative disc diseases at l4-l5 and l5-s1.Neurological review showed numbness and tingling on left foot toes.On (b)(6) 2008: the patient was admitted with following preoperative diagnosis: degenerative disc disease, l5-s1 and l4-l5.She complained of debilitating low back pain and significant axial discomfort from sitting intolerance.She was noted to have significant degenerative disk disease at l5-s1 and also at the l4-l5 level.L5-s1 had significant modic changes.L4-l5 had an annular bulge and degenerative changes.The patient underwent a provocative discogram that reproduced pain at both levels; l5-s1 was most significant.L4-l5 was also very significant in discomfort, and l3-l4 completely benign.The patient underwent the following procedures: anterior lumbar interbody fusion, l5-s1.Extreme lateral interbody fusion, l4-l5, through a separate fascial incision.Biological implant placement x5 (i.E., two peak devices, one from synthes, i.E., a synfix, and one from nuvasive, i.E., an xlif cage, a 12 x 50, and three allograft expanses, biological implants from osteotech).Anterior instrumentation, l5-s1, with a synfix cage and 20-mm x 4-mm screws.Intraoperative monitoring by neuromonitoring services.Per op-note, the final implant came with an anterior plate for arthrodesis purposes and fixation purposes, the device with the peek cage, having expanse and rhbmp-2/acs in the middle chambers, and rhbmp-2/acs in the lateral chambers, was inserted.The device was then implanted.The surgeon selected four 20-mm x 4.0 screws and implanted them in such a manner that it was subsided underneath the plate and had excellent purchase into the bone, confirmed on image intensification.That completed the anterior interbody fusion at l5-s1 with anterior instrumentation.Then under direct vision and under image intensification, a shim was inserted into the disc space at the l4-l5 level that was located at the posterior third, and discectomy was performed.Size 12 cage from nuvasive was implanted with rhbmp-2/acs wrapped around several expanses and then subsequently wrapped with # 1 vicryl in order to prevent stuff from coming out.Shim dilators were placed into the disc space.The cage was advanced appropriately across the midline.Cage placement was confirmed on ap and lateral views.Multiple fluoroscopic images were obtained during the procedures which were compared with the ct scan dated (b)(6) 2008.X-rays had been done of the area that showed no evidence of any foreign body being left.X-ray of the anterior view of the abdomen was obtained that had confirmed nothing being left in the abdomen.No patient complications were reported.On (b)(6) 2008: the patient was discharged with some complaint of back pain but overall she felt pretty comfortable.On (b)(6) 2008: the patient was admitted with following diagnosis: adhesive bowel obstruction status post laparoscopic lysis of adhesions.The patient complained of abdominal pain.Ct of the abdomen showed early or partial small-bowel obstruction with transition point at the ileum.There was no free air.There was small to moderate free fluid in the pelvis.Chronic osteitis pubis.Impression: small bowel obstruction.Recent back surgery for degenerative disc disease with anterior and lateral approach (b)(6) 2008.On (b)(6) 2009: the patient was discharged (b)(6) 2009: the patient presented for postoperative follow up.The patient had complications with early onset of adhesions.The patient had some increased sensation on the left groin at the site of incision.The patient underwent radiological exam of lumbar spine which looked good.On (b)(6) 2009: the patient presented almost five weeks status post-surgery.The patient seemed to be doing well.Radiographs of her lu mber spine of this day showed that both cages were in excellent position.On (b)(6) 2009: the patient presented eight and half weeks out from her surgery.She had sporadic back pain, more on the left side than on the right which depends on her activities.She had little bit of numbness and tingling in her left foot once in a while but that was not consistent.The patient also complained of having trouble sleeping.On (b)(6) 2009: the patient presented status post a front/back procedure.The patient seemed to be doing okay but had some residual pain in the back.The patient underwent radiological exam of lumbar spine, her fusion looked great at l5-s1 level.Apparently, she had good bone coming across at the l4-l5 level with no evidence of subsidence but the concentration of bone was not as intense at l5-s1 level.

• 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: 5027747
• MDR Text Key: 23985827
• Report Number: 1030489-2015-02079
• 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: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• 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: M110706AAC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2008
• 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): Other
• Patient Weight: 80