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

Model Number CTL4.5-022-S

Device Problem Break (1069)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history record for the screw confirmed no deviations in the manufacturing process and that the finished product met all required quality inspections prior to release.A supplemental report will be submitted with device evaluation findings.

Event Description

It was reported that in the early lengthening phase, it was discovered that the patient's tibia was developing a slight procurvatum deformity; however it was decided to continue with the lengthening process.During removal of the plate after lengthening had reached an acceptable result, one of the 4.5mm locking screws in the distal segment of the plate was noted to be broken and it was also discovered that the screw had been implanted with purchase in the near cortex only.Additionally, it was reported the plate had been implanted in an inverted orientation.The surgeon made alignment adjustments and reinforced the surgical site with a static locking plate.Report 1 of 2.

• 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: tiara rae ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 11589047
• MDR Text Key: 242932261
• Report Number: 3006179046-2021-00210
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517029980
• UDI-Public: 887517029980
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTL4.5-022-S
• Device Lot Number: ACAAAE0425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 10 YR