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

Model Number ROSA SPINE 1.0.2

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Code Available (3191)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.

Event Description

Surgeon was unable to perform the patient registration despite several attempts, so he reverted to traditional surgery technique without the robot assistance to perform surgery.

Manufacturer Narrative

The log files analysis performed for investigation purpose shows that the references were not visible when user wanted to perform the registration.There is no indication that the user did not follow the ifu.Moreover maintenance performed after the issue occured did not show any issues regarding visibility or calibration of the references.The root cause cannot be determined on this occasion.

• Brand Name: ROSA SPINE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; 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 Key: 6686201
• MDR Text Key: 79054675
• Report Number: 3009185973-2017-00657
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK151511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROSA SPINE 1.0.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1