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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 Patient-Device Incompatibility (2682)
Patient Problem No Patient Involvement (2645)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
The device sp14005 has been inspected for investigation purpose.All pins changed because of biocompatibility problem detection.
 
Event Description
During an intervention performed on customer site by our field engineer, it was identified that the patient reference pin was non-functional.There was no patient involvement 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 Key6446003
MDR Text Key71255858
Report Number3009185973-2017-00297
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGM
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 Replace
Type of Report Initial
Report Date 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberROSA SPINE 1.0.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2015
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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