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 Ossification (1428); Incontinence (1928); Muscle Spasm(s) (1966); Neuropathy (1983); Loss of Range of Motion (2032); Weakness (2145); Tingling (2171); Cramp(s) (2193); Neck Pain (2433); Ambulation Difficulties (2544); Nerve Proximity Nos (Not Otherwise Specified) (2647)

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.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.

Event Description

It was reported that on (b)(6) 2010, patient underwent spine fusion surgery on the lumbar region of her spine from vertebrae l4 to l5 using transforaminal approach.Reportedly, during the surgery, only select parts of rhbmp-2 collagen sponge were used.The rhbmp-2 collagen sponge was placed outside a cage (i.E.In the disc space).Allegedly post-operative period has been marked by low back pain, with radiating pain into her buttocks, both legs, down into the left calf and across the top of her left foot; weakness in her left leg; swelling in ankles and feet; tingling in both feet; difficulty ambulating; use of a cane or wheelchair; and bladder incontinence.Patient underwent revision surgery on (b)(6) 2013.Surgical findings included significant heterotrophic ossification with direct compression of the exiting right l4 nerve root.These serious injuries prevent patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively.

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2010: the patient presented with following pre-op diagnosis: intractable back and right leg pain believed secondary to advanced degenerative disk changes at l4-l5 with lumbar instability and lateral recess and foraminal stenosis on the right.She underwent following procedures: right l4-l5 decompression for foraminal and lateral recess stenosis; complete discectomy at l4-l5 with transforaminal lumbar interbody fusion using orthosis, bone graft, autograft and hydroxyapatite crystals; percutaneous pedicle screw fixation, l4 to l5 bilaterally using pedicle screws; use of the operating microscope; placement of epidural catheter for postoperative epidural morphine analgesia.As per operative notes,¿pledgets of bmp(bone morphogenic protein) soaked sponge were first placed in the left side of the disk space followed by the 14 x 26 cage containing a pledget of bmp soaked sponge surrounding hydroxyapatite crystal and autograft bone previously harvested from the decompression.An additional sponge with the same content was then placed in the right side of the interspace.¿ no intra-operative complications were reported.The patient got discharged on (b)(6) 2010.

• 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: 5388030
• MDR Text Key: 36753381
• Report Number: 1030489-2016-00262
• 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
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2018
• 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): Required Intervention