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

Model Number 7510800

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

Patient Problems Dysphagia/ Odynophagia (1815); Incontinence (1928); Nerve Damage (1979); Pain (1994)

Event Type  Injury  

Event Description

It was reported by a non medical professional that the patient underwent a posterior lumbar interbody fusion procedure at l2-3, l3-4, l4-5, l5-s1 using rhbmp-2/acs and peek cages.At an unknown time post-op, the patient experienced injuries including nerve damage, chronic pain, dysphagia, and incontinence.

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.

Manufacturer Narrative

(b)(6).

Event Description

A review of the patient's medical records found that: the patient presented to surgery with lumbar degenerative scoliosis, lumbar degenerative disc disease of l2-l3, l3-l4, l4-l5, l5-s1 levels.Lumbar spinal stenosis; moderate at the l2-l3, l5-s1 levels; severe at the l3-l4 and l4-l5 levels.Severe low back pain that radiates bilaterally into legs with associated neurologic claudication.Intractable back pain with degenerative scoliosis.Patient had previous left l5-s1 discectomy with subsequent degeneration.The patient underwent a procedure for posterior lumbar interbody fusion from l2-s1.Anterior instrumentation with cage placement at l2-l3, l3-l4, l4-l5, and l5-s1.Posterior segmental spinal instrumentation at the l2-s1 levels.Posterior lateral intertransverse arthrodesis at the l2-l3 level.Posterolateral intertransverse arthrodesis at the l3-l4 level -additional level.Posterolateral intertransverse arthrodesis l4-l5 level - additional level.Posterolateral intertransverse arthrodesis at the l5-s1 level - additional level.Harvesting of spinous process and lamina autograft for spinal bone grafting procedure.Application of bone morphogenic protein.(b)(6) 2010 procedures: egd performed (b)(6) 2010 showed gastric ulcer, per pyloric with oozing of blood, status post cautery with biopsy taken, which are pending at the time of this dictate on.Discharge diagnoses: (b)(6) 2012 patient admitted for chest pain, released same day, no arrhythmias noted.Ecg findings: sinus rhythm.(b)(6) 2012: stress test performed due to chest pain/discomfort (b)(6) 2013: follow up office visit: musculoskeletal problems as well as sciatica.Patient denies back problems.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3734708
• MDR Text Key: 4220042
• Report Number: 1030489-2014-02110
• 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: 03/13/2014

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: 08/01/2009
• Device Model Number: 7510800
• Device Catalogue Number: 7510800
• Device Lot Number: M110605AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 04/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2007
• 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