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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA SPINE COMPUTER-ASSISTED SURGICAL DEVICE

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MEDTECH SA ROSA SPINE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA SPINE 1.0.2
Device Problem Calibration Problem (2890)
Patient Problem No Patient Involvement (2645)
Event Date 10/26/2016
Event Type  malfunction  
Manufacturer Narrative
The device sp14005 has been inspected for investigation purpose. The tests performed confirmed that the robot registration pattern need to be re-calibrated. The defective parts were re-calibrated in headquarter.
 
Event Description
During an intervention performed on customer site by our field engineer, it was identified that the navigation camera was non-functional. There was no patient involvment reported.
 
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Brand NameROSA SPINE
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer Contact
jay sharma
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR   34000
7414400
MDR Report Key6449662
MDR Text Key71470751
Report Number3009185973-2017-00306
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K151511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Repair
Type of Report Initial
Report Date 03/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA SPINE 1.0.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2015
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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