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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINEOLOGY INC. ELITE; INTERVERTEBRAL BODY FUSION DEVICE
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SPINEOLOGY INC. ELITE; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 541-0014
Device Problem Mechanical Problem (1384)
Patient Problem Missing Value Reason (3192)
Event Date 10/03/2018
Event Type  malfunction  
Event Description
The implant was removed and replaced with another of the same design approximately 11 weeks post-op.Reportedly x-ray imaging indicated that the implant collapsed, and the bolt was broken.No information about the patient's condition is available.
 
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Brand Name
ELITE
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
SPINEOLOGY INC.
7800 third street n.
suite 600
saint paul MN 55128 5455
Manufacturer (Section G)
SPINEOLOGY INC.
7800 3rd street n.
suite 600
st. paul MN 55128 5455
Manufacturer Contact
karen roche
7800 third street n.
suite 600
saint paul, MN 55128-5455
6512568500
MDR Report Key8042082
MDR Text Key126518533
Report Number2135156-2018-00010
Device Sequence Number1
Product Code MAX
UDI-Device IdentifierM7405410014
UDI-PublicM7405410014
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162879
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2022
Device Catalogue Number541-0014
Device Lot NumberS80440
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2018
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 Age75 YR
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