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 Incontinence (1928); Neuropathy (1983); Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that the patient underwent surgery, which was spine fusion surgery on l2-l5.She was implanted with rhbmp-2/acs.Post second surgery, she suffered from progressively worsening low back pain, groin pain and pain radiating into her buttock and down the posterior right leg into the calf and lateral shin, and often into the foot down to the top of her great toe.She developed incontinence.The patient continues to experience chronic lower back pain, groin pain, and pain radiating into her buttock and down her right leg.She continues to suffer from urinary urgency and bladder leakage.She is unable to enjoy her daily activities that she enjoyed pre-operatively, and has suffered serious and permanent injuries.

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 on: on (b)(6) 2014: patient presented with following pre-op diagnosis: recurrent l2-4 central and foraminal stenosis with instability and severe degenerative disk disease.Procedure: a redo l2-4 laminectomy and right multilevel foraminotomies(right l2-3, l3-4 and partial right l4-5) l2-3 and l3-4 tlif with implant, bmp, graft putty, autograft and allograft putty, l2-5 posterior instrumentation withpe dicle screws and rods.Removal of pedicle screws, harvest of local autograft.Stealth stereotactic intraoperative navigation, complex procedure due to extensive scar tissue.Per op notes: the center of the implant was packed with bmp and autograft.Bmp sponges was placed over the decorticated transverse processes from l2 down to l5.On (b)(6) 2014: patient underwent x-ray of lumbar spine 2 views.Impression: normal on (b)(6) 2014: patient underwent x-ray of lumbar spine 2 views.Impression: status post interbody and posterolateral fusion from l2-s1 with posterior spinal fixation.On (b)(6) 2014: patient underwent x-ray of lumbar spine 2 views, impression: posterior fusion l2-5 without complication.On (b)(6) 2014: patient underwent x-ray of lumbar spine 4 views: impression: interbody and posterior instrumented fusion l2-5 shows no radiographic complication.Laminectomy changes l3-4.No instability on flexion or extension.Mild degenerative disk height loss with schmol¿s nodes t12-l1 and l1-2.On (b)(6) 2014: patient underwent x-ray of lumbar spine 2 views.Impression: lumbosacral fusion.On (b)(6) 2015: patient presented with right leg pain.Patient underwent x-ray of lumbar spine 2 views.Impression: lumbar fusion.No abnormal alignment.

• 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: 5079798
• MDR Text Key: 25878683
• Report Number: 1030489-2015-02377
• 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: 05/09/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2015
• Initial Date FDA Received: 09/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• 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): Other
• Patient Weight: 88