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

Model Number 6901222

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation nor were radiographs provided to confirm the alleged event.No allegation of product malfunction reported.No product returned.

Event Description

On (b)(6) 2018, a patient underwent an extreme lateral interbody fusion procedure at l2-l5 levels.During the procedure the anterior longitudinal ligament was damaged at l4/l5 level.As per reporter cages were implanted with no issued in levels l2-l4, but affected level was packed with bone prosthesis anteriorly autogenous bone posteriorly.

• 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: 7578696
• MDR Text Key: 110380682
• Report Number: 2031966-2018-00098
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00887517390509
• UDI-Public: 00887517390509
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 6901222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• 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