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 Dyspnea (1816); Pain (1994); Swelling (2091); Weakness (2145); Burning Sensation (2146); Tingling (2171); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

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) 2010, patient was implanted with rhbmp-2.Procedure: anterior cervical discectomy and fusion (acdf)- extrapharyngeal anterolateral approach on c5-6, c6-7.Initial diagnosis: acdf for treatment of degenerative disc disease (ddd) on (b)(6) 2010, patient reported constipation.On (b)(6) 2010, patient reported incisional swelling, dyspnea with ambulation, neck sensitivity, feeling bloated, paresthesias (tinglins and pressure) on right side of the face.On (b)(6) 2010, patient reported paresthesias (numbness), left upper extremity on (b)(6) 2010, patient reported insomnia.On (b)(6) 2010, patient reported occasional residual paresthesias (numbness, tingling) in right upper extremity.On (b)(6) 2010, patient reported irritability and weight gain associated with smoking cessation.On (b)(6) 2010, patient reported lower back pain.On (b)(6) 2010, patient reported burning pain in right neck and shoulder.On (b)(6) 2010, patient reported progressive numbness and weakness in right hand.On (b)(6) 2011, patient reported sharp stabbing pain in middle of the back.On (b)(6) 2011, patient reported paresthesias (numbness, weakness) in left lower extremity with ongoing mid thoracic pain.On (b)(6) 2011, patient reported right arm pain and concomitant pressure in lower back affecting daily activities.

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: 5955428
• MDR Text Key: 54879021
• Report Number: 1030489-2016-02567
• 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: 08/23/2016

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: 08/23/2016
• 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: 40 YR
• Patient Weight: 67