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 Fatigue (1849); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Neck Pain (2433); Shaking/Tremors (2515)

Event Type  Injury  

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.

Event Description

It was reported that on, (b)(6) 2009, patient underwent acdf for treatment of degenerative disc disease (ddd).Pre-op diagnosis: degenerative disc disease (ddd) on (b)(6) 2009, patient reported easy fatigability.On (b)(6) 2009, patient reported pain in left neck and shoulder and in both arms associated with weakness (left greater than right).On 26 (b)(6) 2009, patient reported ongoing pain "tightness in neck and shoulders unrelieved by current pain management.On (b)(6) 2009, patient reported neck problems (nos).On (b)(6) 2009, patient reported recurrent neck pain with bilateral upper extremity weakness, attributed by clinician to head trauma 6 weeks earlier after reviewing mri,emg and examining patient.Treatment included mri of the c spine w/o contrast and emg/ncv "both were abnormal".On (b)(6) 2009, patient reported new onset pain 3 weeks prior to follow up, specifically right neck pain with radiation to right arm and associated with right hand weakness.Approximately 9 months postoperatively, an abnormal plan films cervical spine x-ray revealed focal kyphosis at c4-c5.On (b)(6) 2010, patient reported progressive neck pain, now w/weakness in both hands.Approximately 8 months postoperatively, mri of the cervical spine revealed a c4-c5 disc herniation w/cord compression; and progressive cervical kyphosis.Approximately 11 months postoperatively, the subject underwent an revision of the acdf with bmp and removal of old hardware with open reduction of kyphosis.On (b)(6) 2010, patient reported leukocytosis and thrombocytosis, most likely reactive in patient with uri.On (b)(6) 2010, patient reported neck and shoulder pain.On (b)(6) 2010, patient reported pruritus attributed to narcotic pain medication.On (b)(6) 2010, patient reported swelling at site of surgical incision.On (b)(6) 2011, patient reported recurrent neck pain and weakness with bilateral hand tremor, subjectively diminished fine motor function, subjective ataxia.

Event Description

Pain, ongoing but improving in neck and shoulders (present prior to acdf), <(>&<)> truncal pain, likely attributable to fibromyalgia.Resolution date: (b)(6) 2009.Easy fatigability resolution date: (b)(6) 2009.Pain in left neck and shoulder, and in both arms with associated weakness (left greater than right); attributed by clinician to myof ascial pain syndrome.Resolution date: (b)(6) 2009.Recurrent neck pain with bilateral upper extremity weakness resolution date: (b)(6) 2009.Date of surgery: (b)(6) 2010, surgery type: revision, treatment levels: c-7, surgery name: acdf w/bmp, successful fusion.Date of surgery: (b)(6) 2010, levels: c4-c5, surgery name: open reduction of kyphosis, successful.Date of surgery: (b)(6) 2010, levels: c3-c4, surgery name: open reduction of kyphosis, successful.Date of surgery: (b)(6) 2010, levels: c4-c5, surgery name: acdf, successful.Date of surgery: (b)(6) 2010, levels: c5-c6 c6-c7, surgery name: removal of old hardware, successful.Resolution date: (b)(6) 2010.On (b)(6) 2011, patient reported recurrent neck pain and weakness with bilateral hand tremor, subjectively diminished fine motor function, subjective ataxia.Incisional swelling from acdf surgery.Resolution date: (b)(6) 2010.

Event Description

Treated levels:c5-c6 approach: extrapharyngeal anterolateral.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5955454
• MDR Text Key: 54879361
• Report Number: 1030489-2016-02573
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• 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
• Date Manufacturer Received: 11/21/2016
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 70