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 Edema (1820); Incontinence (1928); Pain (1994); Tingling (2171); Ambulation Difficulties (2544)

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.Multiple products 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) 2012 patient was admitted to the facility where surgeon performed spine fusion surgery using rhbmp2 on the lumbar region of his spine from vertebrae l4 to s1.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., over the transverse processes).Post-op patient reported to have "increasing low back pain".Patient "continues to experience chronic lower back pain, pain radiating to his lower extremities, numbness and tingling in his lower extremities, and edema.Patient experiences difficulty sitting, standing and walking, reduced mobility, need assistance getting out of bed every day, and requires a cane to ambulate.Patient also suffers from bowel issues, and gastrointestinal issues".

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2012, the patient was presented with the following pre-op diagnosis: 1.L4-s1 spondylosis, foraminal stenosis.2.L5-s1 hnp.Patient underwent the following procedures: 1.Decompression laminectomy and foraminotomies, l4-s1.2.L5-s1 diskectomy, interbody graft.3.L4-s1 pedicle screw fixation with dynamic l4-5, rigid l5-s1.4.L4-s1 transverse process fusion.As per operative notes,¿ diskectomy was then performed to the left of midline cleaning out the disk and preparing the disk and endplates with a series of cutting instruments before placing a globus medical caliber interbody graft, 6 rum in height x 26 mm in length, packed with rhbmp-2.Transverse processes were then decorticated and fusion performed with autologous laminar bone and bone wrapped with rhbmp-2 sponges.¿ no intra-operative complications were reported.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6025338
• MDR Text Key: 57249279
• Report Number: 1030489-2016-02875
• 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,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• 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: 03/19/2018
• 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): Other