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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 SPINE SHORT ADAPTOR
Device Problem Mechanical Jam (2983)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2020
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. Udi#: unknown.
 
Event Description
The 6mm cannula became stuck inside the drill adapter, which the surgeon used a mallet to pass the cannula through the drill adapter. This resulted in a "skived" trajectory.
 
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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 Key10452787
MDR Text Key204387345
Report Number3009185973-2020-00195
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192173
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
Report Date 06/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPINE SHORT ADAPTOR
Device Catalogue NumberROSAS00112
Device Lot NumberROSA3-117B
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 Received06/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2016
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

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