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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 04/20/2016
Event Type  malfunction  
Manufacturer Narrative
The device sp 16 008 has been inspected for investigation purpose.The tests performed confirmed that the calibration file was incorrect.As repair, the calibration file was reviewed and corrected.The internal complaint reference is the following: (b)(4).
 
Event Description
During a device test part of the preventive maintenance, it was identified that the universal navigation handle was non-functional.There was no patient involvment reported.
 
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Brand Name
ROSA SPINE
Type of Device
COMPUTER-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 Key6427667
MDR Text Key70657050
Report Number3009185973-2017-00179
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
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 03/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA SPINE 1.0.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/20/2016
Initial Date FDA Received03/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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