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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problem Imprecision (1307)
Patient Problems Muscle Weakness (1967); Unspecified Nervous System Problem (4426); Insufficient Information (4580)
Event Date 01/05/2022
Event Type  malfunction  
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 if information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that there was a deviation during a l1-s1 degenerative deformity case. The surgical system was mounted to the patient's right psis. The surgeon accurately executed the left l1-l3 trajectories and then moved to the right side. There was a medial deviation/breach with deficit at right l1 and l2. A drill and tap were used through the arm guide. Some screws were placed freehand as they belonged to a separate manufacturer. Pedicle size was noted to be very thin at less than 3 mm and the screws placed were more than 5. 5 mm. This was discussed with the surgeon during the procedure. There was no patient harm and the procedure was delayed less than an hour.
 
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Brand NameMAZOR X SYSTEM
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
IS 3079567
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
IS 3079567
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13451564
MDR Text Key285236625
Report Number3005075696-2022-00006
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K182077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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