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 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

Device sp 14 005 has been inspected for investigation purposes. The robot arm reference was found to be out of calibration. The component was recalibrated and accuracy testing was again completed. Testing confirmed that the component was in specification and fully functional.

Event Description

During preventative maintenance, it was identified that the robot arm reference was out of calibration. There was no patient involvement.

• 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: 6471886
• Report Number: 3009185973-2017-00479
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROSA SPINE 1.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2016
• 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