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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Swelling (2091)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation, a review of radiographs provided confirm the alleged event.It is unknown if patient followed post-operative restrictions or suffered a fall.Even though root cause was unable to be confirmed a review of radiograph and reported information suggests insufficient lordosis created excessive load may have contributed the screws to pull out.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

On (b)(6) 2019, patient underwent a posterior fixation procedure from t11 to l4 levels with no reported issues.On an unknown date, the patient reported back swelling and radiographs confirmed pedicle screws pulled out at t10, t11 and t12 levels.On (b)(6) 2020, a revision took place where all nuvasive products were reportedly removed.No additional issues reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: virnalisa cobacha ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 9668887
• MDR Text Key: 183104127
• Report Number: 2031966-2020-00013
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160989
• 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: 02/04/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR