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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 8657003
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/25/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis results: visual and optical examination identified approximately 2mm of the driver's head has sheared off.The tip was not returned for analysis.Optical inspection of the fracture surface confirmed a very flat fracture surface with circular material flow consistent throughput the fracture.This type of damage is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that intra-op, the instrument tip broke off while expanding the cage.There were no patient symptoms or complications as a result of this event.
 
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Brand Name
ELEVATE SPINAL SYSTEM
Common Device Name
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key8825204
Report Number1030489-2019-00815
Device Sequence Number2337061
Product Code MAX
UDI-Device Identifier00643169432192
UDI-Public00643169432192
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K142559
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number8657003
Device Lot NumberEM16E086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/25/2019
Initial Report FDA Received Date07/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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