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

Model Number	10055445
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product returned for investigation as product remains in-situ.No radiographs or photographs provided to confirm the event.A review of the device history record for lot nu10109 noted no material nonconformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: ".Cross connectors are designed specific to the rod diameter and cannot be used on the tapered section of tapered rods.If using cross connectors on tapered rods, only attach them on constant diameter rod sections." ".All lock screws should be final-tightened with the counter-torque and torque t-handle" ".Preoperative warnings: devices should be inspected for damage prior to implantation.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".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" ".Care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument (reference surgical technique)." still in-situ.
Event or Problem Description
On (b)(6) 2017, a patient underwent a posterior lumbar interbody fusion procedure at l4/5 levels.On (b)(6) 2017 post-operative radiographs showed separation of the connector from the rod.The patient is asymptomatic and no revision surgery is planned at this time.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6904163
• Report Number: 2031966-2017-00131
• Device Sequence Number: 1443343
• Product Code: NKB
• UDI-Device Identifier: 00887517534705
• UDI-Public: 00887517534705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2017

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: Physician
• Device Model Number: 10055445
• Device Lot Number: NU10109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR