MAUDE Adverse Event Report: NUVASIVE, INCORPORATED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; GENERAL INSTRUMENT

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

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation as no product malfunction was alleged.No root cause can be confirmed at this time.

Event Description

On unknown date, a patient underwent a planned extreme lateral interbody fusion procedure at l4-5 level associated with l3-5 posterior decompression and bilateral pedicle screw fixation and fusion from l3 to l5.Bleeding occurred when the cobb dissector was introduced to detach the lower endplate.The lesion was repaired immediately by sutures.The patient was transferred to icu, treated with medications and physical therapy, and was successfully discharged with home medication.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Type of Device: GENERAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: virnalisa cobacha ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 10096413
• MDR Text Key: 193292407
• Report Number: 2031966-2020-00093
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR