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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA ONE
Device Problem Malposition of Device (2616)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 05/06/2020
Event Type  Injury  
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted. Unique identifier (udi) #: (b)(4).
 
Event Description
The neurologist, told the company field service engineer (fse) during a case on (b)(6) 2020 that during the case on (b)(6) 2020 that 3 electrodes turned out to be shallow of the planned target. Each bolt placement was also shifted 2-3 mm towards the top of the skull. The case mentioned on (b)(6) 2020 was an independent case done by the site via facetime support. There was also a brain bleed that occurred in an area that was not near trajectories. The patient did not have any harm due to these complications. The neurologist was not sure of the origin of the bleed. The bleed was left alone and was considered minor by the neurologist. The electrodes were left in the skull for recording. The progress of the recording or if any seizures have been recorded is unknown. The fse described that the placement of the bolts being off could be due to a head shift from using a mayfield frame instead of a crw or leksell since every single bolt was shifted the same about in comparison to the plan. The fse also mentioned that the depth may have been human error while doing calculations.
 
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Brand NameROSA ONE
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
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key10168244
MDR Text Key195920083
Report Number3009185973-2020-00148
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00203
Device Lot Number3.1.1.1295
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/18/2020 Patient Sequence Number: 1
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