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

Model Number 8800000006

Device Problems Detachment Of Device Component (1104); Fracture (1260); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation nor were radiographs or photographs provided to confirm the reported event.It is unknown if the patient complied with post-operative restrictions root cause cannot be determined at this time.Labeling review: potential adverse events and complications: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s) loss of fixation." warnings, cautions and precautions: ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant.Corrosion of the implant can occur.Implanting metals and alloys in the human body subjects them to a constantly changing environment of salts, acids, and alkalis, which can cause corrosion.Placing dissimilar metals in contact with each other can accelerate the corrosion process, which in turn, can enhance fatigue fractures of implants.Consequently, every effort should be made to use compatible metals and alloys in conjunction with each other.Care should be taken to insure that all components are ideally fixated prior to closure." ".Failure to final-tighten the lock screws with the counter-torque and torque t-handle may result in rod and torque t-handle.Do not final-tighten through other instruments in the set.Failure to ensure there is enough rod over-hang when final tightening may lead to improper lock down of the new construct.It may be necessary for the surgeon to add length to the rod, depending upon patient anatomy and desired lordosis.As a general rule, add 15mm.If the measurement is in-between rod sizes, always round up to the next rod length.For long constructs, it may be necessary to add more length." no items returned.

Event Description

Patient underwent a posterior fusion procedure at t10-s2ai levels.Post-operatively radiographs showed a rod fracture at l4-l5 levels and a set screw back out at the s2ai level.On (b)(6) 2017, a revision procedure was completed where the fractured rod and the separated set screw were replaced, the right side rod was re-bent and secured.No patient injury was reported.

• Brand Name: NUVASIVE PRECEPT SPINAL 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: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 6987856
• MDR Text Key: 91333487
• Report Number: 2031966-2017-00154
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122352
• 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: 10/30/2017

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: 8800000006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1