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

Model Number 8848200006

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Radiographs provided confirm the complaint.Review of the reported information identified nuvasive devices were combined with another manufacturer's device which is considered off label use.Patient's bone quality is unknown.Review of surgeon's notes identified the patient was four years post-operative and fully fused and the construct was completely removed.The root cause is considered a component failure related to excessive loading as a result of continued use after fusion was achieved.Implant life expectancy is identified at 2.5 years.No additional investigation necessary.Patient is identified as in good health with successful fusion.Labeling review: ".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 components." ".Warnings, cautions and precautions: these devices can break when subjected to the increased load associated with delayed union or nonunion.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." ".Compatibility: do not use the precept spinal system and nuvasive precept mas plif fixation system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications." ".Lifetime of the device: the expected life cycle of implants is determined through astm f1717 testing astm f1717 standard test methods for spinal implant constructs in a vertebrectomy model.5 million cycle endurance limit in astm f1717 represents 2.5 years of in vivo usage per the rationale presented here: the purpose of spinal fusion implants is to provide short term stability until arthrodesis takes place.Following fusion, the device is expected to be unloaded due to load-sharing with the newly formed bone mass.Spinal fusion should occur within 12 months of surgery.According to hedman¸ et al.1991, the average person makes approximately 2 million strides per year 1 million gait cycles.Testing to 5 million cycles is equivalent to a lifetime of approximately 2.5 years of activity, providing a safety factor of 2.5.".

Event Description

On (b)(6) 2017 a patient underwent a spinal procedure at t12/s2ai.Another manufacturer's cage was inserted at l2 and no cage was implanted at l5.In (b)(6) 2021 a rod was found fractured between l5/s during a routine follow-up.No fall or symptoms of pain were reported.On (b)(6) 2021 removal surgery was performed.Left sacral and iliac screws were loose.Bone fusion was completed at t12/l5.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13114590
• MDR Text Key: 289335905
• Report Number: 2031966-2021-00190
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517314642
• UDI-Public: 887517314642
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8848200006
• Device Lot Number: CT59419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 43 KG