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 Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Inadequate Pain Relief (2388); 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.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) 2007, the patient underwent anterior lumbar interbody fusion surgery from vertebrae l5 to s1.Reportedly, rhbmp-2/acs was used in this surgery.Post-op, the patient suffered from increasing severe back pain, with pain radiating up his back and down into his left buttock.He continued to experience chronic lower back pain and muscle spasms, with pain radiating throughout his back and into his left buttock.He could not sit, stand or walk for extended periods, had difficulty in sleeping due to pain, and required use of a cane to assist in ambulation.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

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) 2007: the patient was pre-operatively diagnosed with degenerative disc disease involving l5-s1 and underwent the following procedures: anterior retroperitoneal exposure of l5-s1 with mobilization of the iliac vessels and subsequent closure of the abdominal wound.Discectomy of l5-s1 anterior interbody fusion of l5-s1 using bone graft with bone morphogenic protein.Application of plate and screws.As per the operative notes ".Following mobilization of the vessels and exposure of the l5-s1 bodies and disks we approximated the center of our marking this with a spinal needle.Ap and lateral views were taken to confirm the center as well as the correct l5-51 bodies and disks and were in the right places.The surgeon then came and proceeded with a diskectomy, fusion, and application of plate and screws while i helped him.The omnitrac retractors were then removed and the final ap and lateral views were taken.The instrumentation looked good and in good positions.The ureter and peritoneum were inspected and both are intact.The vessels were also inspected and these are intact.There was good hemostasis.¿ the patient tolerated the procedure well without any intraoperative complications.The patient was pre-operatively diagnosed with l5-s1 degenerative disc disease and central disc herniation and underwent the following procedures: l5-s1 anterior lumbar discectomy.L5-s1 arthrodesis.Placement of structural allograft at l5-s1.Anterior plating at l5-s1.As per operative notes, ".Disk material was then removed using the pituitary rongeur.More disk material and end plate was mobilized using curettes and removed.The synthes auf spacer system was utilized.Serial trial spacers were placed up to a 15 mm spacer which provided adequate distraction and with good purchase.A 15 mm spacer was then selected.The central portion of the spacer was packed with the rhbmp2-acs sponge.The graft was then delivered into the disk space using the squid guide.It was tapped in slightly further using the bone tap and mallet, and an x-ray obtained confirming good position of the graft.The synthes anterior lumbar plate was selected.A 39 mm plate and 24 mm screws were utilized.The plate was secured using holding pins.¿ 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: 5767797
• MDR Text Key: 48711998
• Report Number: 1030489-2016-01956
• 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: 10/27/2017

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: 11/01/2009
• Device Catalogue Number: 7510200
• Device Lot Number: M110604AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/04/2016
• Supplement Dates Manufacturer Received: 06/08/2016; 10/09/2017
• Supplement Dates FDA Received: 09/23/2017; 10/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2006
• 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