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 Swelling (2091); Weakness (2145); Tingling (2171); Disc Impingement (2655)

Event Type  Injury  

Manufacturer Narrative

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

Procedure: anterior cervical discectomy and fusion (acdf)-extrapharyngeal anterolateral implant level (s): c4-c5, c5-c6 initial diagnosis: acdf for treatment of degenerative disc disease (ddd) it was reported that on (b)(6) 2009, patient underwent anterior cervical discectomy and fusion where rhbmp-2 was used in the patient.On (b)(6) 2009, patient reported inability to place foley catheter in operating room (patient has urethral stricture from prostatectomy in 2008).On (b)(6) 2009, patient reported feeling "very sleepy" post-operatively.Onset (b)(6) 2009, patient reported incisional swelling.On (b)(6) 2010, patient reported "tightness", bilateral trapezius muscles.On (b)(6) 2009, patient reported intermittent paresthesia (tingling), bilateral lower extremities.On (b)(6) 2011, patient reported dysesthesia/paresthesia/weakness, recurrent, in neck, shoulders, arms.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2011, the patient underwent mri without contrast, cervical spine.Results: abnormal, degenerative disc disease with ascending severity at c3-4,4-5,5-6; large herniation, c5-6, with severe cord impingement ; displacement.

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: 5942170
• MDR Text Key: 54396469
• Report Number: 1030489-2016-02522
• 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: health professional,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided; 09/21/2016
• Supplement Dates FDA Received: 10/14/2016; 09/25/2017
• 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: 61 YR
• Patient Weight: 92