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

Model Number 8828580006

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation.Photographs of x-ray images were provided and alleged event cannot be confirmed.Labeling review: contraindications ".Contraindications include but are not limited to: infection, local to the operative site." ".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)." ".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." 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 even though restrictions in activity are followed." post-operative warnings: ".During the postoperative phase, it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications." unknown if product remains in-situ.

Event Description

On (b)(6) 2017, a patient underwent a posterior fixation procedure at l1-s2a1 levels.Reportedly, screws were not placed at the s1 level.On (b)(6) 2018, set screw separation was detected at the left side of s2a1 level.Patient experienced minor pain but has refused to have a revision procedure.No patient injury 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: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 7397354
• MDR Text Key: 104436708
• Report Number: 2031966-2018-00033
• Device Sequence Number: 1
• Product Code: NKB
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2018

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: 8828580006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/04/2018
• 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