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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAZOR ROBOTICS LTD

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MAZOR ROBOTICS LTD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Incontinence (1928); Nerve Damage (1979); Pain (1994); Seroma (2069); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
Clinical export data and log files were received and thoroughly inspected. Post operative ct scans were received and compared to the pre-operative planning that was prepared for the case. Deviations were noted at the t10 - t12 and l1 right levels. The deviation nature was consistent with the left trajectory appearing medial to the original plan and the right trajectory appearing laterally placed to the original plan. Upon review of the operation flow, the attempt at instrumenting the t10 to l1 region started at l1 left and continued up to t10 left, then down the right side. The t10-l1 segment was performed after the l2-s2 segment. The l2-s2 segment was deemed accurate intra-operatively and was confirmed to be accurate in post-operative scans. After reviewing all available information, no indication of malfunction of the system during the surgery was found. If information is provided in the future, a supplemental report will be issued.
 
Event Description
This event was previously reported under report #3005075696-2018-00031.
 
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Manufacturer (Section D)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
3079567
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
3079567
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8928698
MDR Text Key155471459
Report Number1723170-2019-04621
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K180307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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