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); Weakness (2145); Burning Sensation (2146); Tingling (2171); Discomfort (2330); Numbness (2415)

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 the patient underwent surgery on (b)(6) 2011 levels implanted: c3-c4,c4-c5, c5-c6,c6-c7 type of procedure (including approach): anterior cervical discectomy and fusion (acdf)- extrapharyngeal anterolateral approach initial diagnosis: acdf for treatment of degenerative disc disease (ddd) on (b)(6) 2011, patient reported migratory dysesthesia (pain, burning), paresthesias (numbness, tingling), involving upper and lower extremities; exacerbated by activities of daily living, fatigue.On (b)(6) 2011, patient underwent mri w/o contrast, cervical spine.Results: normal.On (b)(6) 2011, patient underwent radiographic test of lateral cervical spine films.Results: normal.On (b)(6) 2011, patient underwent electromyelogram, nerve conduction study (emg/ncv).Results: normal.On (b)(6) 2011, patient underwent radiographic test lateral cervical spine films.Results: normal.On (b)(6) 2012, patient underwent mri w/o contrast, cervical spine.Results: normal.On (b)(6) 2012, patient underwent electromyelogram, nerve conduction study (emg/ncv).Results: normal.On (b)(6) 2012, patient reported discomfort, interscapular, dysesthesia (pain, weakness), paresthesia (numbness) affecting previously unaffected areas of right arm and digits of right hand; exacerbated by work-related repetitive motion.Over next months diagnostic studies confirmed successful c-spine fusion w/o complications <(>&<)> confirmed right c-7, possible c-8 radiculopathy; no further work up/neurosurgical intervention indicated.

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: 5999211
• MDR Text Key: 56444620
• Report Number: 1030489-2016-02755
• 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
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• 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: 09/08/2016
• 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): Other
• Patient Age: 51 YR
• Patient Weight: 86