• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problem Dysphagia/ Odynophagia (1815)
Event Type  Injury  
Manufacturer Narrative
Literature citation:brendan p.Lovasik, christopher m.Holland, brian m.Howard, griffin r.Baum, gerald e.Rodts, daniel refai "anterior cervical discectomy and fusion: comparison of fusion, dysphagia, and complication rates between recombinant human bone morphogenetic protein-2 and beta-tricalcium phosphate." mean age 56 yrs, 53 male, 31 female.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 in the literature titled ¿anterior cervical discectomy and fusion: comparison of fusion, dysphagia, and complication rates between recombinant human bone morphogenetic protein-2 and beta-tricalcium phosphate¿ that 84 patients underwent acdf (anterior cervical discectomy and fusion) surgery during a 2 year period form april 2011 to april 2013 in which rhbmp-2 was used for fusion.The most common indications for surgery were any or a combination of the following: cervical myelopathy, radiculopathy, spondylosis, and anatomic instability.A smith-robinson anteromedial approach was used in all cases; all bone graft supplements were secured fully inside the peek cage or allograft and were combined with autologous bone marrow aspirate and morcelized osteophyte fragments when btcp was used.An anterior cervical plate was applied in all cases.Dosing of rhbmp2 and btcp were approximately 0.5 mg and 1.2 ml per cervical level, respectively.Nearly 1 in 5 patients (n =35, 18.3%; 17 from rhbmp-2 group) reported symptoms of postoperative dysphagia.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6434957
MDR Text Key70861231
Report Number1030489-2017-00602
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,literatur
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/01/2017
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? Yes
Initial Date Manufacturer Received 03/01/2017
Initial Date FDA Received03/27/2017
Supplement Dates Manufacturer Received03/01/2017
Supplement Dates FDA Received10/02/2017
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 Age56 YR
-
-