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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SARL VIPER PRIME NAVIGATION ADAPTOR ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameVIPER PRIME NAVIGATION ADAPTOR
Type of DeviceORTHOPEDIC 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 Key7361712
MDR Text Key103176911
Report Number1526439-2018-50269
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170937
Number of Events Reported1
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 Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286750133N
Device Catalogue Number286750133N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
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
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