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

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

Patient Problems Neuropathy (1983); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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 on (b)(6) 2011: patient underwent chest x-ray for pre-op evaluation.Impression: normal chest.On (b)(6) 2011: patient had laminectomy accessed from the back side in the past with placement of cages for spinal fusion.However, the patient had slippage of the cage and currently has significant grade 2 spondylolisthesis.Patient was here for repeat operation; however, approach from the anterior aspect.Pre-op diagnosis: spondylolisthesis of l4-l5.Patient underwent following procedures: anterior retroperitoneal spine exposure for l4-l5; exploratory laparotomy for hemorrhage (concern injury to ivc/right iliac vein).Per op notes, surgeon encountered brisk bleeding coming from the contralateral side through the l4 defect.At this point, surgeon was able to control the bleeding by holding pressure on the contralateral iliac vein.Surgeon also placed packing at this area and was able to control temporary hemostasis this way.The patient was hemodynamically stable.The patient remained intubated, transferred back to icu bed and taken to the recovery room in stable condition.Specimens removed: two cages.Complications: bleeding requiring exploratory laparomy for exposure or control of hemorrhage.Pre-op diagnosis: spondylolisthesis of l4 on l5.Patient underwent following procedures: anterior retroperitoneal exposure of spine for l4 and l5; exploratory laparotomy for hemorrhage.No complications reported.Patient underwent surgery approximately 5 months ago; surgeon did bak cages.In his initial surgery he encountered torrential bleeding and had to be abandon surgery, and had to bring her back a few days later to place the other bak cage.Initially patient did well, clinically, and then she had the return of her back and leg pain.X-rays and cat scans showed of her episode of spondylolisthesis, initially grade 1 and then she progressed to grade 2.She also had radiculopathy.Pre-op diagnosis: l4-l5 grade 2 spondylolisthesis in a patient with bilateral bak cages.Patient underwent following procedures: left-sided anterolateral approach; removal of bak cages; placement of allograft chips and bmp; midline approach for vascular exploration.Per op notes, patient she was mildly coagulopathic and had received 6 units of blood and surgeon had decided to pack the defect with allograft chips rolled in one large kit of bmp.The patient was hemodynamically stable through out the operation.The complications were venous bleeding requiring midline approach.After closure, the patient was transferred to the icu in stable condition.Central venous catheter placement and arterial line placement were performed.Patient underwent chest x-ray.Impression: et tube tip approximately 4.5 cm from the carina.Right ij catheter tip in the distal svc.No pneumothorax.On (b)(6) 2011: patient presented for pain management.Patient underwent chest x-ray.Impression: interval placement of esophagogastric tube.Persistent right lateral basilar scar/atelectasis.Otherwise unchanged.On (b)(6) 2011: patient underwent ct lumbar spine without contrast.Impression: status post removal of l4-5 bak cages with grade 2 anterolisthesis l4 on l5; bilateral pleural effusions and basilar atelectasis; small amounts of retroperitoneal and pelvic free fluid.On (b)(6) 2011: patient underwent ct chest with contrast due to increasing oxygen requirements.Impression: no evidence of pulmonary embolism; bilateral pleural effusions with substantial compressive atelectasis involving both lower lobes; right upper lobe pneumonia; marked distention of the common bile duct; status post gastric stapling, probable rectus sheath hernia partially visualized on most inferior images; premature coronary artery calcifications.Patient underwent lower extremity venous duplex.Patient presented with left lower extremity edema and left iliac vessel injury from surgical repair of broken spine.Impression: negative for deep vein thrombosis, right lower extremity; acute deep vein thrombosis, left lower extremity.On (b)(6) 2011: patient presented with pre-op diagnosis: needs mechanical prophyaxis against pulmonary embolism.Patient underwent retrievable infrarenal ivc filter implant procedure.Impression and findings: successful deployment of retrievable infrarenal cook incorporated gunther tulip ivc filter; inferior vena cava angiography showing no evidence of intraluminal thrombus and demonstrating a normal size/configuration vessel; ultrasound examination showed widely patent right common femoral vein.Patient underwent chest x-ray due to increasing oxygen requirements.Impression: progression of bilateral airspace disease.On (b)(6) 2011: patient underwent chest x-ray due to increasing oxygen requirements.Impression: mild to moderate pulmonary edema, less pronounced when compared to previous.

• 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: 5159179
• MDR Text Key: 28649638
• Report Number: 1030489-2015-02732
• 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: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• 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): Required Intervention
• Patient Weight: 63