MAUDE Adverse Event Report: NUVASIVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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

Patient Problem Blood Loss (2597)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation as no product malfunction has been alleged.No radiographs or images to confirm the reported event.It is unknown if a nuvasive product caused or contributed to this event.Review of the reported information suggests intra-operative error attributed to the alleged event.

Event Description

On (b)(6) 2019, a patient underwent a surgical extreme lateral interbody fusion (xlif) procedure on the l4 to l5 vertebral levels.During the procedure, there was an increase in bleeding and patient was placed in supine position.It is unknown where the bleeding occurred.Reportedly, there was no harm to the patient intra-operatively and post surgery.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121 ; 8589093383
• MDR Report Key: 8664868
• MDR Text Key: 146892921
• Report Number: 2031966-2019-00202
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR