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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
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.
 
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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 Key5942170
MDR Text Key54396469
Report Number1030489-2016-02522
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
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 Received09/12/2016
Supplement Dates Manufacturer ReceivedNot provided
09/21/2016
Supplement Dates FDA Received10/14/2016
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 Number1
Patient Outcome(s) Other;
Patient Age61 YR
Patient Weight92
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