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 Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (persisting back pain, revision surgery).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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2005, patient was admitted to the facility, where the surgeon performed spine fusion surgery involving rhbmp2 on the lumbar region of her spine from vertebrae l4 to s1.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op, patient had "progressively worsening low back pain and radiculopathy in both lower extremities"."severe pain led to two revision surgeries on (b)(6) 2014 and (b)(6) 2014".Post-op, patient reported "chronic lower back pain, with stabbing and shooting pain radiating from her lower back to her lower extremities, numbness and tingling in both feet, and numbness in parts of her thighs and feet".Patient reported "difficulty sitting, standing and walking, her legs give out without warning, and she requires a cane or scooter to assist in ambulation.Plaintiff also suffers from bladder dysfunction".

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was presented with following pre-operative diagnosis: l4-5 and l5-s1 degenerative disk disease with annular tear/protrusion.She went underwent the following procedures: l4-l5 and l5-s1 anterior lumbar interbody fusion.Anterior lumbar plating.Placement of allograft interbody biomechanical fusion cage.Placement of rhbmp-2/acs with cancellous allograft chips.Left retroperitoneal approach.As per the op-notes,¿ an annulotomy/discectomy and preparation of the end plates with curettage and shaping it in place to fit an 18 mm vg-1 graft.The posterior annulus was explored and did show annular tearing centrally.All disk material was decompressed from the disk space and from the annular tear.The 18 mm graft was then inserted which gave good restoration of disk space height.Decompression of the neural foramina with restoration of lordosis.The allograft cage was prepared by inserting rhbmp-2/acs saturated on sponge wrapped around crushed cancellous allograft chips and placed in the central portion.Surgeon then packed it.The construct was further stabilized using a synthes.A tb (anterior tension band) plate placing 26 mm screws and a 24 mm screws at l5 giving quite secure fixation.Similar annulotomy/discectomy was performed at l4-5 with end plate curettage and preparation performed.The discectomy was done with thorough removal of disk particles and the annular tear somewhat larger on the left side at l4-5 was found.All disk material was evacuated from the area.The annular tear had a similar fitting with a vg-1 graft and rhbmp-2 construct was performed and plating with a synthes plate using 24 mm screws.All screws were secured to the manufacturer's recommended torque.Floseal was placed in the disk space for additional hemostasis, and bleeding had stopped at the conclusion of the reconstruction.The closure was then performed by the surgeon.The patient was aroused from anesthesia, taken to recovery from the operating table, with the patient having tolerated the procedure well.¿.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 6207991
• MDR Text Key: 63359480
• Report Number: 1030489-2016-03558
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other