MAUDE Adverse Event Report: NUVASIVE, INC. GENERAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Bone Fracture(s) (1870); Blood Loss (2597)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation nor has allegation of product malfunction been reported.It is unknown if the same instrument was used at the time of reported events.A review of xray films provided cannot confirm alleged event.

Event Description

On (b)(6) 2018, a patient underwent an extreme lateral interbody fusion procedure at the t12-l2 levels.As per reporter, during the procedure an xlif instrument reportedly got stuck in the vertebral body and unplanned bleeding occurred.Cell saver was used on the patient and procedure continued.Intra-operatively while shaving a vertebral body an instrument got stuck at the l1 level resulting in a broken bone.At this time it is unknown how much blood was loss, patient was reported to have recovered smoothly.

• Brand Name: GENERAL INSTRUMENTS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 7742251
• MDR Text Key: 115792853
• Report Number: 2031966-2018-00123
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 63