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

Model Number	13117540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Xray films provided do not confirm alleged event.Labeling review: contraindications: contraindications include, but are not limited to: patients with inadequate bone stock or quality.Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: fracture of the vertebra.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.
Event or Problem Description
On (b)(6) 2019, patient underwent an interbody fusion procedure with posterior fixation on the l4 to s1 vertebral levels without any reported issues.Approximately one month post-operative, patient began experiencing pain on the right side and difficulty walking.Postoperative images revealed that patient had experienced a sacrum fracture.On (b)(6) 2019, patient underwent a revision procedure where the lock screws were replaced and construct was extended.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8626028
• Report Number: 2031966-2019-00195
• Device Sequence Number: 1654736
• Product Code: NKB
• UDI-Device Identifier: 00887517582775
• UDI-Public: 887517582775
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 13117540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR