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 Unspecified Infection (1930); Pain (1994); Swelling (2091); Discharge (2225); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that the patient underwent a 360 posterior and anterior fusion l4-s1 utilizing rhbmp-2/acs with a cage in the alif portion of the surgery.Post-operatively the patient developed an infection that would not resolve.The patient had been to the doctor twice and received medicine but did not help.The patient also reported that the infection is not at the incision line - it is located at the right crease side in between hairline and right groin.The patient had swelling up in his groin.Culture was taken and the results are pending.The patient also reported that there was knot, drainage, and swelling.The patient reported that the symptoms started about 2 months ago and the primary care doctor was treating the infection.The patient also complained that he cannot sit on hard objects including a toilet seat; his legs get numb and he has a hard time getting off of the toilet.Both left and right legs were affected.The patient was still experiencing numbness and pain down to feet.

Manufacturer Narrative

Concomitant medical products: cage (implant (b)(6) 2014).(b)(4).(b)(6).Neither the device nor applicable imaging study films or patient medical records 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/used 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)(4).

Event Description

It was reported that on (b)(6) 2008 patient presented for left shoulder arthroscopy, rotator cuff repair and had the following procedures: extensive debridement of shoulder, synovectomy, slap repair, subacromial decompression, ac joint resection, capsulorrhaphy, rotator cuff repair, placement of antibiotic pump.On (b)(6) 2009, patient underwent anterior decompression, fusion, instrumentation c4-7 due to the pre-op diagnosis of cervical radiculopathy.Osteocel allograft cellular bone matrix was used in the surgery on (b)(6) 2012, patient underwent posterior decompression, fusion instrumentation c4-7 due to the pre-op diagnosis of cervical radiculopathy.Osteocel allograft cellular bone matrix was used in the surgery and affix ii plate size 35 mm was also used in the surgery.On (b)(6) 2012, patient underwent lateral lumbar fusion due to the pre-op chief complaint of lumbar radiculopathy.Osteocel allograft cellular bone matrix was used in the surgery.On (b)(6) 2012, patient underwent the following procedures: posterior lumbar fusion, l3-l4, 2.Posterior lumbar instrumentation , l3-l4 nuvasive affix posterior spinal plating, nuvasive peek 18 mm magnitude cage at l3-4, 4.Morsellized osteocel plus allograft, intraoperative fluoroscopy.Intraoperative ssep with emg monitoring with remove monitoring and interpretation by surgeon for approx.One hour without complication to treat the pre-op diagnosis: lumbar discogenic pain.Lumbar radiculopathy.On (b)(6) 2014, the patient underwent the following operations: anterior lumbar interbody fusion, l5-s1.Instrumentation, l5-s1, using cage instrumentation and lumbosacral plating system fixation to treat the pre-op diagnosis: severe discogenic pain, l5-s1.Severe lumbar radiculopathy, l5-s1.The following implants were used in the surgery: peek cage size 14mm x 12 deg.Large foot print.Lumbosacral plate size 41 mm with a total of 4 unicortical screws fixation and the locking mechanism activated at the end.Procedure done with ssep, emg and fluoroscopy monitoring.Op note: the radical discectomy of l5-s1 done first, followed by fusion again using peek cage 14 mm x 12 deg.By a large foot print and finally the application of the lumbosacral plate with a total of 4 unicortical screws fixation and the locking mechanism activated at the end.Sponge count reported as correct twice and the abdomen and pelvis scanned with c-arm for foreign body scanning were negative.The patient was extubated, awakened and sent to recovery room in satisfactory condition.On (b)(6) 2014, the patient underwent the following procedure: anterior lumbar interbody fusion, l5-s1.Anterior lumbar instrumentation, l5-s1, using anterior lumbar plate, 14 mm peek cage.Rhbmp-2/acs bone morphogenic protein.Intraoperative fluoroscopy.Intraoperative ssep with emg monitoring with remove monitoring and interpretation without complication to treat following the pre-op diagnosis: lumbar discogenic pain.Lumbar radiculopathy.Op note: the surgeon selected 14 mm peek cage filled with bone morphogenic protein and impacted this into place at l5-s1 level.All implants were placed under fluoroscopic guidance.Intraoperative ssep with emg monitoring was performed during the procedure with remote monitoring and interpretation by irrigation was performed only prior to placement of rhbmp-2/acs.The patient transferred to the recovery room in stable condition.Discectomy of l5-s1 done first, followed by fusion again using peek cage 14 mm x 12 deg.By a large foot print and finally the application of the lumbosacral plate with a total of 4 unicortical screws fixation and the locking mechanism activated at the end.Sponge count reported as correct twice and the abdomen and pelvis scanned with c-arm for foreign body scanning were negative.The patient was extubated, awakened and sent to recovery room in satisfactory condition.No other information was provided.

• 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: 4461215
• MDR Text Key: 17577259
• Report Number: 1030489-2015-00207
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M1113011AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• 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