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

Model Number	LP4.5-MLT4B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Deformity/ Disfigurement (2360)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of device history record for the plate confirmed no deviations in the manufacturing process and that the finished product met all required quality inspections prior to release.Should relevant additional information become available, a supplemental report will be filed.
Event or Problem 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.It was also reported the plate had been implanted in an inverted orientation.The plate was removed after lengthening had reached an acceptable result and the surgeon made alignment adjustments and reinforced the surgical site with a static locking plate.Additionally, it was reported that during plate removal, 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.Report 2 of 2.
Event or Problem Description
Additional information was received that a superficial wound infection was diagnosed.The infection is believed to be the result of prominent hardware in an area of limited soft tissue coverage.Additionally, the tension of the soft tissue over the plate increased and contributed to wound breakdown.
Additional Manufacturer Narrative
Additional data.

• 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: 11589054
• Report Number: 3006179046-2021-00211
• Device Sequence Number: 3546995
• Product Code: KTT
• UDI-Device Identifier: 00887517021687
• UDI-Public: 887517021687
• 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): 07/13/2021

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: Health Professional
• Device Model Number: LP4.5-MLT4B
• Device Lot Number: 0071317AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/14/2021
• 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: Required Intervention
• Patient Age: 10 YR