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

Model Number	13115540
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were radiographs provided to confirm the complaint.".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s).Pain, discomfort or abnormal sensations due to the presence of the device." ".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." no product returned.
Event or Problem Description
On (b)(6) 2017, a patient underwent posterior spinal fusion at the t7-l2 levels.On (b)(6) 2017, a xray film indicated 4 screws loosening at the l1-l2 levels.A revision surgery was performed on (b)(6) 2017, to replace the loosened screws with screws with the larger diameter.No patient injury was reported.

• 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: 6792226
• Report Number: 2031966-2017-00106
• Device Sequence Number: 13732213
• Product Code: NKB
• UDI-Device Identifier: 00887517582218
• UDI-Public: 00887517582218
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2017

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: No Information
• Device Model Number: 13115540
• Device Lot Number: SA1560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR