MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	8854535
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hypoesthesia (2352); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product not returned and could not be evaluated.Provided radiographs confirm the alleged malfunction.Review of the reported information suggests undersized implant selection and/or excessive loading as the root cause.No additional investigation needed.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 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.Care should be taken to insure that all components are ideally fixated prior to closure." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".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." device discarded at user facility.
Event or Problem Description
On (b)(6) 2021 a spinal procedure was done on a patient with scoliosis.Post-op images reveal that the screws were bent inside the vertebrae.On (b)(6) 2021 a revision procedure was done where the nuvasive screws were replaced with a competitors' brand.No patient injury or symptoms were reported.
Additional Manufacturer Narrative
The alleged issue could not be confirmed as the screws that were returned were in no way bent.The root cause of the issue is unknown, but may be the result of incorrectly evaluated radiograph distortion.No additional investigation can be completed.

• Brand Name: NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11476330
• Report Number: 2031966-2021-00042
• Device Sequence Number: 17043543
• Product Code: NKB
• UDI-Device Identifier: 00887517380470
• UDI-Public: 887517380470
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8854535
• Device Lot Number: JP2568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8854030; 8854035; 8855040
• Patient Age: 12 YR