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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC OSTEOFIL; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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MEDTRONIC OSTEOFIL; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Auguste, k., chin, c., acosta, f., and ames, c., (2006) expandable cylindrical cages in the cervical spine a review of 22 cases.J neurosurg spine, 4: 285-291.The authors discussed their experience in using expandable cylindrical cages (ecc) in the reconstruction of the cervical spine in 22 patients with various pathological conditions.All patients underwent a standard anterior cervical corpectomy.The ecc constructs were supplemented with posterior instrumentation in patients with neoplastic processes or those requiring two-or multilevel corpectomies and with a preoperative kyphotic deformity greater than 15?.The synthes in-space implant was used for the percutaneous implantations.Native bone harvested from the corpectomy site was used as bone graft material.In patients with osteomyelitis or metastatic cancer the competitor's bone material product was used.Overall, the combination of corpectomy and ecg-augmented fusion led to improvements in kyphotic deformities, restoring structural support, and appeared to be well tolerated.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
OSTEOFIL
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC
MDR Report Key17530670
MDR Text Key321132479
Report NumberMW5137588
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 10/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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