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 Incontinence (1928); Pain (1994); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that a patient underwent a posterolateral and transforaminal lumbar interbody fusion surgery from l5 to s1 on (b)(6) 2010 using rhbmp-2/acs.The rhbmp-2 was placed in the posterolateral gutters.Sometime postop, the patient reportedly experienced pain in his lower back, radiating to his lower extremities, as well as numbness in both his legs and is unable to stand or walk for long periods.The patient uses acane to ambulate.The patient also developed debilitating bowel and bladder incontinence and has difficulty sleeping.

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.

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with the following pre-op diagnosis: l5-s1 grade i isthmic spondylolisthesis.Lumbar stenosis, l4 to s1 severe foraminal stenosis l5.Chronic low back pain.Bilateral radiculopathy left greater than right.Left foot drop and underwent the following procedure: gill's procedure l5.Partial bilateral laminectomy, l4.Additional level partial bilateral laminectomy s1.Bilateral lateral recess decompression, l4-5.Bilateral lateral recess decompression l5-s1.Bilateral internal foraminotomy, l5.Transpedicular instrumentation spanning l5-s1 utilizing 67.5 x 45 mm screws x2 at l5 and 7.5 x 40 mm screws x2 at s1.Posterolateral spinal fusion spanning l5-s1.Transforaminal lumbar interbody fusion l5-s1.Insertions of anterior prosthetic device 13 x 10 x 22 mm.11.Use of bmp collagen sponges, large kit.Use of local autograft.Use of demineralized corticocancellous allograft.Utilization and supervision of fluoroscopic services totaling less than 1 hour.Utilization of a free fat graft.Use of floseal hemostatic agent in which rhbmp2/acs was used.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3895008
• MDR Text Key: 4540013
• Report Number: 1030489-2014-02908
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• 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: 01/29/2018
• 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