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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 Device Difficult to Setup or Prepare (1487)
Patient Problem No Code Available (3191)
Event Date 06/09/2017
Event Type  Injury  
Manufacturer Narrative
The log files analysis performed for investigation purpose shows that the references were not visible when user wanted to perform the registration. There is no indication that the user did not follow the ifu. Moreover maintenance performed after the issue occured did not show any issues regarding visibility or calibration of the references. The root cause cannot be determined on this occasion.
 
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose. Once the evaluation will be performed, a follow-up medwatch report will be submitted.
 
Event Description
Surgeon was unable to perform the patient registration despite several attempts, so he reverted to traditional surgery technique without the robot assistance to perform surgery.
 
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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
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
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key6686201
MDR Text Key113448024
Report Number3009185973-2017-00657
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK151511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROSA SPINE 1.0.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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