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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. MEDTRONIC SPINAL GRAFT TECH T FIBERCELL VIABLE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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MEDTRONIC SOFAMOR DANEK USA, INC. MEDTRONIC SPINAL GRAFT TECH T FIBERCELL VIABLE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Model Number MATRIX10CC
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Bacterial Infection (1735); Fever (1858); Muscle Weakness (1967); Seroma (2069); Chills (2191)
Event Date 03/08/2021
Event Type  Injury  
Event Description
On (b)(6) 2021 patient underwent an anterior lumbar interbody arthrodesis at l5-s1 followed by a posterior spinal fusion with instrumentation.On (b)(6) 2021, an mri revealed fluid collections at the surgical site level.On (b)(6) 2021, a repeat mri revealed multiple abscesses at the surgical site level.The patient was readmitted on (b)(6) 2021 with complaints of intermittent fevers, chills, and weakness and had subsequent ir guided drainage of abscess on (b)(6) 2021.Afb culture revealed (b)(6) result of (b)(6).
 
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Brand Name
MEDTRONIC SPINAL GRAFT TECH T FIBERCELL VIABLE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC.
MDR Report Key11912525
MDR Text Key253754277
Report NumberMW5101626
Device Sequence Number1
Product Code NEK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/08/2023
Device Model NumberMATRIX10CC
Device Catalogue NumberVBM9910
Device Lot Number'NMOS210011006'
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other; Required Intervention;
Patient Age46 YR
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