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

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Pain (1994); Paralysis (1997); No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation nor were images provided to confirm the alleged event.It is unknown if patient followed post-operative restrictions or suffered a fall.Patient's bone quality is reported as fragile.Review of patient medical history identified 3 previous procedures.Even though root cause cannot be confirmed review of information provided indicates potential root cause may be related to patient's pathology and bone quality.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: if healing is delayed, or does not occur, the implant may eventually loosen.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 and 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." ".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." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration.".

Event Description

During a post-operative exam from a previous procedure on (b)(6) 2020, loose screws were discovered at the t7 level.On (b)(6) 2020, the patient underwent a revision procedure to extend fixation level to t3 and replace loose screws at t7 levels without any reported issues.

Manufacturer Narrative

No product has been returned for evaluation nor were images provided to confirm the alleged event.It is unknown if patient followed post-operative restrictions or suffered a fall.Patient's bone quality is reported as fragile.Review of patient medical history identified multiple surgical procedures.Even though root cause cannot be confirmed review of information provided indicates potential root cause may be related to patient's pathology and bone quality.Labeling review: ".Contraindications: contraindications include but are not limited to: 4.Patients who are unwilling to restrict activities or follow medical advice.5.Patients with inadequate bone stock or quality.6.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.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." ".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: if healing is delayed, or does not occur, the implant may eventually loosen.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 and 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." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration.".

Event Description

Additional: on (b)(6) 2020, the patient experienced a physical paralysis because th2 had slipped to anterior and dislocated.On (b)(6) 2020, the patient underwent a revision surgery.In the revision surgery, vue point screws were added to c5, and reline screws were implanted to th1 and th2.No screws were added to c6 and c7.It seems that the physician will observe the patient for a while.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10687854
• MDR Text Key: 211909326
• Report Number: 2031966-2020-00192
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K160989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR