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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2022
Event Type  Injury  
Manufacturer Narrative
Analysis results of the software exports and logs were not available as of the date of this report. A follow up report will be submitted when analysis is complete. 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 were multiple misplaced screws during the procedure. All of the misplaced screws were medial between 3. 5-10 mm. The surgical system was mounted to the patient using a schanz arm connected to a schanz pin placed in the right psis. The surgeon was on the left side of the patient and implanted ipsilateral pedicle screws from l4-s1. The surgeon then implanted ipsilateral l4-s1 from the right side. Then they implanted a contralateral s2ai screw from the patient's right. The surgeon finally implanted the patient's right s2ai screw from the left side of the patient. All were medial except one of the s2 screws. An accuracy check had been run after placing the l5 right and the system appeared accurate at that time. No patient shift or soft tissue tension was noted when placing the screws during this open procedure. Minimal retraction was needed. The maligned screws were noticed in a postop ct scan. There was no spin performed to check the placement of the implants intraoperatively. A separate revision was planned to revise the screws. The procedure was not delayed.
 
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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 Key14219046
MDR Text Key290159058
Report Number3005075696-2022-00038
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
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
Date Returned to Manufacturer04/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/27/2022 Patient Sequence Number: 1
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