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

Catalog Number 7510800

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

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient demographics: (b)(6).It was reported per patient¿s medical records that on: (b)(6) 2008: the patient was admitted with the pre-op diagnosis of spinal stenosis l3-4.He underwent minimal invasive percutaneous tlif (transforaminal lumbar interbody fusion) l3-4 and nerve root decompression l4, left side.As per op-notes, ¿¿bone morphogenic protein as well as master graft was introduced into the anterior aspect of the disk space.Next the appropriate size interbody cage was introduced, also filled with bone morphogenic protein¿¿ ¿¿bone morphogenic protein as well as master graft was then placed¿¿ the patient tolerated the procedure well.The patient also underwent x rays of the lumbar spine.Impression: posterior localization foraminotomy or discectomy changes at l3 and l4 with pedicle screws placed in satisfactory position in l3 and l4 levels.(b)(6) 2009, the patient underwent mri thoracic spine without contrast.Impression: scoliosis; mild desiccation of the intravertebral disc spaces.(b)(6) 2009: the patient underwent epidurography.The patient also underwent mri of the lumbar spine.Impression: scoliosis.Mild desiccation of the intervertebral disc spaces.(b)(6) 2009, the patient underwent ct-guided left sacroiliac joint steroid injection.(b)(6) 2009: the patient underwent epidurography due to low back pain on the left.Impression: left l5-s1 facet joint injection with 40mg of kenalog and 2 ml of bupivacaine as described above.(b)(6) 2009: patient underwent mri of thoracic spine without contrast.Conclusion: right thoracic scoliosis with multilevel disc desiccation.Mild remote wedging of t6, t7, t11 and t12 with endplate irregularities secondary to schmorl¿s node formation.No prevertebral or retro spinal soft tissue injury.No signs of osseous stress injury or acute fracture.T6-7, shallow left paracentral protrusion with annular rent indents the thecal sac without cord compression, central canal stenosis or foraminal stenosis.Multilevel cervical disc displacements most pronounced at c6-7 with suspected mild central canal stenosis and moderate left foraminal narrowing.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6699461
• MDR Text Key: 79574571
• Report Number: 1030489-2017-01709
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2010
• Device Catalogue Number: 7510800
• Device Lot Number: M110610AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2007
• 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
• Patient Weight: 87