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

Catalog Number 7510600

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

Patient Problems Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Swelling (2091); Inadequate Pain Relief (2388); Numbness (2415); Sleep Dysfunction (2517); 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) 2014, the patient underwent anterior lumbar interbody fusion surgery from vertebrae l5 to s1.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space).Post-op, the patient suffered from increasing low back pain, left hip pain, and numbness and swelling in her left leg and foot.Patient continued to experience chronic back pain, with pain radiating across her hips and down her legs, constant swelling on her left side and left ankle, numbness in her left leg, and a rash on both legs.Patient also experienced bladder and bowel issues.Patient was unable to bend over, had difficulty sleeping due to extreme pain, cannot stand for long periods of time, and has difficulty walking.

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) 2014, the patient was pre-operatively diagnosed with diskogenic low back pain and underwent the following procedures: 1) anterior decompression at l4-5 and l5-s1 2) anterior lumbar fusion at l5-s1 with 14mm x 23mm cages, a large kit of rhbmp-2 and crushed cancellous allograft 3) disc replacement at l4-5 with prodisc-l (medium, 6 degree 10mm) with two sheets of rdx2 adhesion barrier.As per op-notes,¿ the anterior rectus fascia was incised and the rectus was reflected laterally.The retroperitoneal space was entered and a balfour retractor was placed.At this point, a large kit of rhbmp-2 was prepared per protocol and placed on the back table and allowed to cure.Surgeon began at l5-s 1.The middle sacral vessels overlying the disc were cauterized with a bipolar and ligated.The center of the disc was marked and surgeon turned attention to l4- 5.At l4-5, the sympathetic chain overlying the disc was cauterized with a bipolar and ligated.There was one large iliolumbar vein which was tied and double clipped and this allowed excellent exposure.Both discs were marked and the image intensifier was brought into position which confirmed our location in both ap and lateral planes.Surgeon began at l5-s 1.A block discectomy was performed over and above the simple block discectomy, surgeon identified a central disc herniation and annular tear and this was debrided until no further compression of the dura was noted.Surgeon then sized the space and elected to use 14 mm x 23 mm cages.Surgeon set the reamer at 29 mm, reamed and placed a bed of deep crushed cancellous allograft followed by two rhbmp-2 sponges, then one sponge per cage and one sponge lateral to each cage with additional crushed cancellous allograft.Pictures were obtained and showed good position of the devices and we turned our attention to l4-5.At l4-5 again a block discectomy was performed.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 5740610
• MDR Text Key: 47897451
• Report Number: 1030489-2016-01844
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 7510600
• Device Lot Number: M111204AA8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2014
• 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