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

Catalog Number 7510400

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

Patient Problems Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).( back pain ; leg pain ; bladder and bowel issue.

Event Description

It was reported that on (b)(6) 2013, patient underwent posterior lumbar interbody fusion and posterolateral fusion surgeries.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage(i.E., in the posterolateral gutters).Reportedly, "patient's post-operative period was marked by a period of improvement, followed by increasing low back pain, with radiating pain to her left hip, leg and foot, and numbness and tingling in her left leg.Patient has difficulty sitting, standing and walking due to pain and also suffers from bladder and bowel issues.".

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 the patient was pre-operatively diagnosed with back pain.Leg pain.Disk space degeneration.Disk space collapse, l4-s1.5.Foraminal stenosis.Lateral recess stenosis.Back and leg pain and underwent the following procedures: l5 laminectomy.L4 laminectomy.3.L5-s1 posterior lumbar interbody fusion using peek cages and autograft spine local.Decompression s1, l5 nerve roots as well as l4 nerve roots.Cortical screw placement l4-s1 intraoperative use of electromyogram (emg) frameless computer slereolaxis.Arthrodesis using autograft spinal local rhbmp-2/acs l4-s1.As per the op notes: ¿after we felt we had adequate decompression, we entered the l5-s1 disk space with a variety of pituitary rongours and curretes after 11 blade was used to cut into the disk space.Dilatation was carried out to 10 using the tangent bone dilators.Right endplate was prepared with rotating cutter, side cutter or, arid 10 x 22 peek cage with rhbmp-2/acs and autograft spine local was placed into location.Contralateral dilator was removed and then using the rotating cutter, side cutter, and 10 x 22 peek cage with rhbmp-2/acs was placed there.We tried to consider doing the same at l4-l5 however any little movement of the thecal sac or the nerve root resulted in the stimulation on the and it was felt that any type of distraction would be unsafe for the patient.¿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: 6020006
• MDR Text Key: 57054669
• Report Number: 1030489-2016-02859
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 7510400
• Device Lot Number: M111201AA2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2013
• 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