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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 09/21/2016
Event Type  malfunction  
Manufacturer Narrative
This issue was linked to a not installed device. Device was used for pre-registration testing at time of event. Therefore this is not a reportable complaint.
 
Manufacturer Narrative
The device (b)(4) was inspected for investigation purposes. The tests performed confirmed that all tools were properly calibrated and that the kinévérif test has a bug. The internal complaint reference is the following: (b)(4).
 
Event Description
During a device test as part of the preventative maintenance, it was identified that the kinévérif test was non-functional. There was no patient involvement 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, 34000
FR 34000
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, 34000
FR 34000
Manufacturer Contact
jay sharma
zac eureka
900 rue du mas de verchant
montpellier, 34000
FR   34000
7414400
MDR Report Key6460136
MDR Text Key130542629
Report Number3009185973-2017-00460
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K151511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 10/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2017
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 Received09/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
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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