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

Model Number	286750133N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• MDR Report Key: 7361712
• Report Number: 1526439-2018-50269
• Device Sequence Number: 11026032
• Product Code: OLO
• UDI-Device Identifier: 10705034507804
• UDI-Public: (01)10705034507804
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286750133N
• Device Catalogue Number: 286750133N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR