MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 13550000

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation.A review of the x-ray films provided confirm a disassociated lock screw.Potential adverse events and complications: "as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." "final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.It may be necessary for the surgeon to add length to the rod, depending upon patient anatomy and desired lordosis." patient education: "the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." post-operative warnings: "during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." no product returned for evaluation.

Event Description

On (b)(6) 2017, a patient underwent posterior lumbar fusion at the l2-l5 levels.On (b)(6) 2017, separation of a lock screw was noted at l5 level.Patient underwent a revision surgery to replace the disassociated lock screw.No patient injury was reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 6879520
• MDR Text Key: 88014715
• Report Number: 2031966-2017-00125
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 00887517551702
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143684
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 13550000
• Device Lot Number: JP13611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• 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