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

Catalog Number 7510800

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

Patient Problems Fall (1848); Loss of Range of Motion (2032); Weakness (2145); Stenosis (2263); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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) 2005, the patient underwent anterior lumbar interbody fusion from vertebrae l4 to s1 and also underwent posterior spinal fusion surgery from vertebrae l4 to l5 on (b)(6) 2005 using rhbmp-2 and collagen sponge.Post-op complications: progressively worsening and chronic back pain, with pain, weakness and radiculopathy in legs.As a result patient had suffered falls.The patient was unable to twist, bend, reach, or lift without pain.The patient was used to be very active and strong and could not participate in sports and hobbies as the patient was enjoying prior to surgery.Sexual intercourse was also painful.Severe pain and symptoms compelled the patient to underwent revision surgery.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

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 (b)(6) 2005: patient having history of low back pain radiating down to the left lower extremity, got admitted in hospital, and was diagnosed pre-operatively with: degenerative lumbar spondylosis with herniated nucleus pulposus, l4-l5, status post previous fusion, l4-l5, and interbody disc replacement, l5-s1.Patient underwent the following procedures: posterior laminectomy for bone harvest at l4-l5; posterolateral and transverse process interfacet laminar fusion with rhbmp-2 allograft, autograft, and prp matrix, l4-5; implantation of pedicle screw and rod fixation, l4-5; somatosensory evoked potential and direct pedicle screw simulation technique.Per op-notes, ¿using the pedicle screw and rod fixation system, appropriate drilling, tapping, and placement of 4.5 upto 5.5 screws were done at l4 and l5¿ excellent fixation occurred¿ the bmp sponge was packed into the facet complex with matrix, and the bone allograft, autograft, and bmp were packed along the lamina and pars and the transverse process region.¿ no intra-op complications were reported.On (b)(6) 2005: patient was provided consultation for pain management, as her pain was not adequately controlled after the surgery.Patient complained of having pain in the surgical area, which was radiating down to the right lower extremity.Patient underwent a trial of physical therapy, epidural injection and pain medication.Impression: lumbar degenerative disc disease with annular tear l5-s1, status post anterior lumbar interbody fusion l4 to s1 on (b)(6) 2005.Plan for posterior surgery on (b)(6) 2005; post-operative anemia; asthma.

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 (b)(6) 2005: per billing records, patient underwent ct of lumbar spine without contrast.On (b)(6) 2005: per billing records, patient underwent ekg test.On (b)(6) 2005: per billing records, patient underwent x-ray of lumbar spine.On (b)(6) 2006: per billing records patient underwent some radiological tests.On (b)(6) 2006:per billing records, patient underwent ct of thoracic spine with contrast, lumbar spine with contrast.

• 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: 5382373
• MDR Text Key: 36463916
• Report Number: 1030489-2016-00220
• 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,Followup
• Report Date: 12/20/2016

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
• Device Catalogue Number: 7510800
• Device Lot Number: M115004AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/05/2016; 07/01/2016; 01/16/2017
• 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): Required Intervention
• Patient Age: 47 YR