MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SCREWS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number CTL4.5-040-S

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation as it remains in-situ.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that a revision procedure was performed in (b)(6) 2021 to address loose screws.As per the reporter, approximately two and a half weeks post-implantation, it was discovered that the screws in the proximal bone segment had loosened and disengaged the plate.No patient adverse event was reported.During the revision, the screws were re-tightened and the screw holes were back-filled with cement to prevent future screw back-out.Post revision, the patient has successfully resumed lengthening.Report 3 of 3.

• Brand Name: PRECICE SCREWS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656
• MDR Report Key: 11712092
• MDR Text Key: 247012713
• Report Number: 3006179046-2021-00254
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517029874
• UDI-Public: 887517029874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTL4.5-040-S
• Device Lot Number: ACAEAD0826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• 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 Outcome(s): Hospitalization