MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL VIPER PRIME NAVIGATION ADAPTOR ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 286750133N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Not Applicable (3189)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During an l5-s1 posterior lumbar interbody fusion using our viper prime system dr. Rob whitmore inserted multiple screws under navigation with the medtronic stealth system. The medtronic suretrack clamp was attached securely to the viper prime navigated screwdriver and then manually calibrated into the stealth system. The navigation seemed to be working well until the 3rd screw when the surgeon noticed that the navigation was off. We spun the o-arm which confirmed that 2 of the screws were not where he intended them to be. We had to change his technique and instead use a jamshidi needle and k-wires. There was no harm to the patient but it added time to the procedure. Patient consequence?: no. Action taken for procedure:the surgeon changed his technique and used a navigated jamshidi needle and k-wires to complete the procedure. Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

• Brand Name: VIPER PRIME NAVIGATION ADAPTOR
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7361712
• MDR Text Key: 103176911
• Report Number: 1526439-2018-50269
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 286750133N
• Device Catalogue Number: 286750133N
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/22/2018 Patient Sequence Number: 1