MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	CTL4.5-044-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information has been provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that during removal, the locking screw broke.It is believed that the screw broke due to excessive torque applied from the power drill.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the received screw revealed the screw to be broken, confirming the reported event.Functional testing was unable to be performed due to the condition of the screw.Dimensional testing was performed and the screw was found to be within specifications.The root cause of the reported event was likely due to excessive torque applied to the screw while utilizing the power drill.Device history review: a review of the device history records indicated that the screws met all dimensional and quality inspections prior to shipment.
Event or Problem Description
N/a.

• Brand Name: PRECICE PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11887051
• Report Number: 3006179046-2021-00285
• Device Sequence Number: 4322370
• Product Code: KTT
• UDI-Device Identifier: 00887517029850
• UDI-Public: 887517029850
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: Health Professional
• Device Model Number: CTL4.5-044-S
• Device Lot Number: ACBNAD0525
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR