MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME NAVIGATION ADAPTOR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	286750133N
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Nerve Damage (1979); Injury (2348); No Code Available (3191)
Date of Event	03/11/2019
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
It was reported that the spine fusion of th9-l3 for th12 thoracic vertebral fracture was performed on (b)(6) 2019 by using medtronic o-arm stealth 7 and viper prime navigation instrument by following the instruction manual.Starting from superior for fixation, 6 screws for th9-11 were successfully inserted into pedicle by confirming with ct image.Then, the surgeon continued to insert the screws for rest of the position.When the surgeon has inserted the 11th screw for l3 left, the surgeon felt abnormality of the insertion of the screw which might have been deviated of the navigation.Then, the surgeon checked the connection part of the tracking unit and recognized that the connection part was loosened.Thus, the surgeon tightened the connection part.After the surgeon inserted the last screw, when the surgeon checked the condition of the screw insertion by ct image, the surgeon recognized screws of l2 left and l3 left were misaligned to inside.The unilateral laminectomy was performed because the surgeon suspected the damage of dura.L3 left screw caused no damage of the dura so that the surgeon removed the l3 left screw and reinforced by neoveil sheet.However, as for l2 left screw, the dura was seriously damaged, and the screw penetrated the cauda equina nerve and was damaged.Thus, the surgeon tried to suture the dura by 7-0 prolene as much as possible.The surgeon also performed reinforcement for the nerve tissue by using neoveil sheet and beriplast.After these reinforcements, the surgeon inserted the screw by using guidewire.After the surgery, the surgeon confirmed the driver was set up properly, and recognized that the loosening of the connection part could not have been detected by visual inspection.There was 180 min.Surgical delay.No further information was provided by the hospital.Note: date of event has been updated to (b)(6) 2019 per request of loc.

• Brand Name: VIPER PRIME NAVIGATION ADAPTOR
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8489610
• Report Number: 1526439-2019-51513
• Device Sequence Number: 16833901
• Product Code: OLO
• UDI-Device Identifier: 10705034507804
• UDI-Public: (01)10705034507804
• Combination Product (Y/N): N
• PMA/510(K) Number: K170937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/05/2019
• 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: 82 YR