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

Model Number ROSA SPINE 1.0.2

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The device sp14005 has been inspected for investigation purpose.The tests performed confirmed that the robot registration pattern need to be re-calibrated.The defective parts were re-calibrated in headquarter.

Event Description

During an intervention performed on customer site by our field engineer, it was identified that the navigation camera was non-functional.There was no patient involvment reported.

• 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 Key: 6449662
• MDR Text Key: 71470751
• Report Number: 3009185973-2017-00306
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151511
• Number of Events Reported: 1
• 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: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ROSA SPINE 1.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1