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 Dysphagia/ Odynophagia (1815); Bone Fracture(s) (1870); High Blood Pressure/ Hypertension (1908); Pain (1994); Weakness (2145); Hernia (2240); Injury (2348); Depression (2361); Neck Pain (2433); Osteopenia/ Osteoporosis (2651)

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

Per medical records, it was reported that on: (b)(6 )2003: the patient presented with pre-op diagnosis of l4-5, l5-s1 lumbar spondylosis, degenerative disc disease at l4-5 and l5-s1.For which patient underwent following procedures: anterior lumbar interbody fusion, l4-5 and l5-s1 with cage and rhbmp-2/acs (4 cages - 16 x 23 mm in dimension); l4-5 diskectomy; l5-s1 diskectomy.Per op notes, the l4-5 disk space was exposed first.Each side of the disk space was reamed and sequentially placed with a 16x23 mm cage.The l4-5 disk was then removed and an anterior interbody cage fusion was performed.Similarly at l5-s1 level again diskectomy was performed and anterior interbody cage was placed.Under fluoroscopic guidance the cages were aligned properly.(b)(6) 2005, (b)(6) 2006, (b)(6) 2007, (b)(6) 2008, (b)(6) 2009: the patient presented for an office visit for spine care follow-up.(b)(6) 2006, (b)(6) 2009: the patient underwent gyn cytology report.Diagnosis: negative for intraepithelial lesion or malignancy atrophic change present.(b)(6) 2006, (b)(6) 2007, (b)(6) 2008, (b)(6) 2009, (b)(6) 2011, and(b)(6) 2012, (b)(6) 2013: the patient underwent mammogram screening.Impression: negative; there was no evidence of suspicious mass or microcalcifications.(b)(6) 2006: the patient presented for an office visit with complaint of diplopia and ptosis.Impression: right hypertropia with right lower face droop/weakness and left ptosis.(b)(6) 2006: the patient underwent ct of head without contrast.Impression: no acute abnormality.Probably incidental choroid or other neuroepithelial cyst left brain.(b)(6) 2007: the patient presented for an office visit with complaint of body ache.(b)(6) 2007: the patient underwent esophagram test due to dysphagia and gastroesophageal reflux disease.Impression: small hiatus hernia with spontaneous gastroesophageal reflux to the level of the thoracic inlet.No frank cricopharyngeus hypertrophy.(b)(6) 2007, (b)(6) 2009: the patient underwent "pap" test which were negative.(b)(6) 2008: the patient presented for an office visit with complaint of pain in back, under shoulder blade, just above hip bones, left leg and hip area.Patient also underwent x-ray of cervical and lumbar spine due to pain in neck and lower back.(b)(6) 2009: the patient underwent toxicology testing for medication oxycodone.(b)(6) 2009: the patient presented for an office visit with complaint of back pain and refill of her medications.Assessment: hypertension, need vaccination for flu.(b)(6) 2010: the patient called up regarding problem of rotator cuff tear in l shoulder and was in pain.Patient wanted to know if cortisone would work.(b)(6) 2010: the patient presented for an office visit with complaint of hip pain.Assessment: back pain, chronic; muscle pain; back strain, lumbar (b)(6) 2010: the patient presented for an office visit with complaint of back pain.Assessment: muscle pain; back strain, lumbar; back pain, chronic.(b)(6) 2010: the patient presented for an office visit with complaint of arthritis hands, sciatic pain.Assessment: rotator cuff tear 3x; back strain, lumbar; osteoarthritis, hands; raynaud's syndrome as improved; sciatica, bilateral as worsened.(b)(6) 2010: the patient presented for an office visit with complaint of thumb pain and refill of medication hydrocodone, and morphine.Assessment: osteoarthritis, hands; sciatica, bilateral; hypertension; degenerative joint disease, hand-right thumb.(b)(6) 2010: the patient presented for an office visit with complaint of left shoulder pain, elevated back pain.She also had a torn rotator cuff in her l.Shoulder.She was having pains down the left front of her shoulder.Assessment: bursitis, left shoulder; shoulder pain, left.(b)(6) 2010: the patient presented for an office visit with complaint of shoulder pain, sciatic pain.Assessment: bursitis, left shoulder; shoulder pain, left, sciatica, bilateral; rotator cuff tear 3x has improved; hypertension, benign.(b)(6) 2011: the patient underwent for urinalysis and complained of finger pain, back pain.Assessment: menopausal syndrome; osteopenia.Patient also underwent for cytology test.Diagnosis: negative for intraepithelial lesion or malignancy atrophic change present.(b)(6) 2011: the patient underwent colonoscopy to cecum with polypectomy.Impression: multiple small polyps removed with cold biopsy.(b)(6) 2011: the patient presented for an office visit with complaint of back pain- neck to sciatic pain, left shoulder pain.(b)(6) 2011: the patient presented for an office visit for bp check.(b)(6) 2011: the patient had cortisone shot in the shoulder and complained of depression.Assessment: degenerative disc disease.(b)(6) 2011: the patient presented for an office visit with complaint of shoulder pain and for extension of medical leave.Assessment: bursitis, subdeltoid; rotator cuff injury, right shoulder.(b)(6) 2011: the patient underwent x-ray arthrogram of right shoulder.Impression: successful right shoulder arthrogram prior to mri.Patient also underwent mri ue joint without contrast.Impression: complete full thickness tear involving the supraspinatus tendon.Full thickness tears involving the superior half of the inferior spinatus tendon with longitudinal tears extending through the substance of the tendon.Postoperative change with prior rotator cuff repair.Degenerative blunting of the labrum without evidence of focal tear.(b)(6) 2011: the patient underwent x-ray arthrogram of left shoulder due to left shoulder pain and history of chronic injury.Impression: successful left shoulder arthrogram prior to mri (b)(6) 2011, (b)(6) 2012: the patient presented for physical exam prior to undergoing shoulder surgery.(b)(6) 2011: the patient presented with following pre-op diagnosis: recurrent large rotator cuff tear, right shoulder.For which patient underwent following procedure: 1.Arthroscopic revision partial rotator cuff tear, infraspinous and subscapularis.2.Arthroscopic revision decompression.3.Arthroscopic debridement with biceps tenotomy, tuberoplasty, and supraspinatus debridement, right shoulder.After which patient had following post-op diagnosis: 1.Recurrent massive rotator cuff tears supraspinatus, infraspinatus, and proximal subscapularis tendons.2.Partial biceps tendon tears.3.Subacromial impingement.The patient tolerated the procedure well and no patient complications were noted.(b)(6) 2012: the patient presented for an office visit with complaint of chronic pain uds pain contract pain film.Impression: rotator cuff injury, right shoulder.(b)(6) 2012: patient reported via call of decreased appetite from her citalopram.(b)(6) 2012: the patient presented for a follow up visit for her chronic pain and sciatic pain.Assessment: sciatica, bilateral; degenerative disc disease; rotator cuff injury, right shoulder.(b)(6) 2012: the patient presented for an office visit with complaint of sciatica, depression follow-up, refill of depression medication and fusion.Assessment: anxiety depression.(b)(6) 2012, and (b)(6) 2013: the patient presented for an office visit with complaint of anemia, chronic pain, general medical evaluation and flu shot.The problem is located low back.The quality was described as low back pain that radiated down bilateral legs/ and shoulders.Impression: anemia; rotator cuff injury, left shoulder; degenerative disc disease.(b)(6) 2012: the patient presented with following pre-op diagnosis: 1.Chronic rotator cuff syndrome with full-thickness rotator cuff tear, supraspinatus tendon, left shoulder.2.Subscapularis tendon tear, left shoulder.For which patient underwent following procedure: 1.Arthroscopic limited debridement of biceps tendon, left shoulder.2.Open rotator cuff repair of the supraspinatus and upper infraspinous.3.Open rotator cuff repair, subscapularis.4.Open decompression, left shoulder.The patient tolerated the procedure well and no patient complications were noted.(b)(6) 2013: the patient presented for an office visit with complaint of chronic back pain.The location of the problem is low back, sciatica right getting worse and over the right sacroiliac joint.The quality is described as nerve pain, shooting bilateral legs.Impression: sacroilitis, right.(b)(6) 2013: the patient presented for an office visit with complaint of incontinence, chronic sciatic pain and fractured fibula.Patient also had problem with ankle pain at left ankle.The quality was described as swollen, constant pain, tight.Assessment: fracture, fibula left; urinary incontinence; cystitis.Patient also underwent x-ray of left ankle.Impression: spiral fracture of the fibula.(b)(6) 2013: the patient presented for an office visit with complaint of ache in leg due to fractured fibula.Assessment: fracture, fibula left.(b)(6) 2013: the patient presented for an office visit with complaint of sinus issues.Assessment: rhinitis medicamentosa.

• 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: 5083447
• MDR Text Key: 26003451
• Report Number: 1030489-2015-02401
• 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
• Report Date: 08/24/2015

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: 7510400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• 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): Other
• Patient Weight: 67